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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94874

26 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 14, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
GE Medical Systems, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

26 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 26

SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2459-2024
Recall number
Z-2459-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
834 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 907373MR, 2058773T, 251435MR3T, 480507MR2, 928475MR1, SMITOMARC, 928348MR, 480425MR10, 510SHARMR, 310680DVMR, 213825DVMR4, 510HHARCMR, SMCARC3TMR, 510204ARMR, 415723SHMR22, 415723CHMR5, 925734ARMR, 650723NCMR3, UCDACC3TMR, 415CPCHMR1, 415CPCHMR2, RADNETMR635, 720848MR3, 303467MR2, 719333MR3T, 203739DDI3T, 860679750W, 302733MR3T, 352VAMR3T, 904223MR2, 904202MR15, 904202MR14, 561747MR3, 904VA3T, 850494MR3T, 772VRAMR3TARCH, 4046053TMR, 47830TMR, 912819MR, 630893MR, 630DMGMR3T, 312355MR3, 312702KMR3T, 312702MR3T, 630527MR1, 630527MR2, 1000003629, 312227750WMR, GON5407114, 217528MR4, 217528MR3, 812450MR2, 812842MR2, 913MMC750W, 337898MR2, 985NOMR4, 504CHMR3, 504VAMR3, BRIGHAM750WMR1, 617499MR3, 781SSHMR3, 413794MR3T, 240555AMR2, 202476MR5, 218249ARC3, 612467MR1, 763278ARC3T, 507372MRARC, 573884MR30, 417347MR2, 314MERCYOPMR1, 406751K3T3, 406751K3T2, 336832MR750, 402IMM3T, 201639MR3T, 973971MR3, 201445750W, 775882GBIMR, 702731MR750W, 518262MR750W, 718616MR3T, 718434MR, 718780MR3T, 716845MR, 631623MR750, 914734MR, 315UBJARCH, 718670MR3T, 516NS7113T, 212562MR1, COR568101, 212523MR3, WCIWMR1, WCIWMR2, 212477MR, RADNETMR1694, CHONYMR10, MSK53MR02, COR526967, 516798MR3T, 631726MR3T, 718226MR3T, 631638MR3T, 516231MR3T, 631376MR3T, 716845AMR, 330489MR3T, 513584MR4, 513584MR3, 216739MR3T, 614293MR9, 937641MR2, 937298MR2, 513636LMR1, 419557MR3T, 405271UMR2, 405752ICMR2, 918502MR2, 918502MR1, 484426MR, 484526MR3T, 412914MR, GON5421098, 814877MR750W, 814262MR3T, 215829MR3T, 412648MR2AR, 412623MR750W, 717764MR, 843777ARC3T, 605504MRARC, 605328MRARC, 605333MRARC, 901545MR3T, 901226MR3T, 9015163TARCH, 615342MR3T2, 615769MR3T, 325670HMR3T, 817472MCA3T, 5129013TO, 5129013T, 214559SRH3TMR, 214341PDDMR1, 903416TMMR2, 817329BSW3TMR, 956296MR750, 956389MR750, 713442KSMR3, 281NWARCHITECT, 713791VAMR3W, 281348MR2, 806UMCHWMR3T, 806775MR3T, 972665XBPMR2, 972708PDPMR1, 281274MR2, 830UMHARC3, 801LONEMR3, 801262MR4, 801373MR6, 801588MR3, 435251MR3, 757312MR3T, 703573ARC2, 703699MR1, 703573ARC6, 703698MR5, 703573ARC7, 703858MR2, 703737MR, 703982MR1, 757953SPMR, 8042893T, 425392PBMR, 425201750W, 360744HM750MR, 360696MR1, 920454MR1, 920568MR1, 608CHILDMR1, 608VAMR750W, 608265MR750W, 608263MR5W, 414955MR2, 414454MR1, 304293MR3T, MR8261AR, MR7862AR, MR6393AR, MR8406AR, MR9103AR, MR6042AR, MR1122AR, 83194303621, 83161978004, 83181649825, 83092403928, 83112923777, 83112923995, 83137149889, 834MR000003, 83178784816, 83164744322, 83193159006, 83104203907, 83187371397, MR52744011, 140024MR01, 130083MR05, 220826MR01, 220826MR02, 210013MR02, MRUA2200, MRUA1963, MRUA2152, MRUA1211, MRUA2006, MRUA1220, MRUA1042, MRUA0394A, MRUA2116, MRUA0976, BG4009MR02, 403777SIGNA3T, 780699MR3T, 905527MR1, 4799583MR11, E416249MR2, 905684MR3T, 506648MR4, 604582MR750, MR102094WH0, MRUA1656B, 082427110155, 082427110104, 082427110144, 082427040255, 082427220090, 082427220086, 082427110161, 082427110151, 082427140308, 082427100469, 082427090479, 082427030204, 082427100447, 082427140212, 082427100459, 082427090476, 082427130144, 082427230222, 082427160284, 082427040333, 082427120261, 082427180067, 082427150132, 082427090470, 082427090456, 082427010212, 082427010180, 082427160360, 082427160276, 082427230170, 082427120292, 082427120272, 082427250121, 082427030219, 082427140197, 082427030218, 082427100464, 082427140303, 082427100493, 082427170042, 082427170026, 082427150129, 082427120271, 082427280030, 082427180053, 082427060112, 082427090461, 082427190196, 082427190169, 082427190168, 082427150128, 082427150140, 082427160358, 082427160429, 082427160313, 082427160401, 082427160356, 082427180060, 082427180085, 082427180054, 082427170049, 082427070256, 082427070314, 082427070263, 082427010198, 082427010187, 082427090487, 082427090467, 082427040320, 082427090488, 082427090465, 082427090493, 082427090494, 082427090457, 082427090472, 082427090446, 082427090489, 082427090437, 082427090438, 082427090432, 082427090469, 082427210248, 082427210257, 082427210217, 082427210212, 082427120344, 082427120372, 082427120351, 082427120349, 082427120295, 082427120377, 082427120337, 082427200214, 082427200223, 082427030203, 082427030222, 082427030211, 082427030171, 082427030223, 082427040270, 082427140345, 082427070283, 082427080139, 082427090490, 082427190200, 082427130126, 082427130121, 082427160409, 082427140330, 082427200226, 082427290044, 082427040274, 082427200182, 082427200209, 082427090503, 082427110130, 082427070331, 082427090483, 082427080138, 082427160423, 082427100520, 082427120262, 082427200230, 082427120254, 082427250138, 082427310183, 082427210223, 082427210258, 082427160325, 082427160280, 082427160339, 082427160354, 082427070245, 082427210233, 082427090390, 082427090406, 082427120284, 082427130129, 082427060089, 082427060120, 082427060115, 082427060125, 082427060122, 082427300031, 082427140340, 082427160355, 082427100518, 082427130176, 082427100486, 082427100480, 082427100487, 082427100491, 082427130125, 082427310170, 082427080144, 082427080145, 082427310150, 082427080127, 082427080147, 082427230241, 082427050054, 082427270086, 082427270078, 082427250098, 082427250136, 082427250107, 082427250106, 082427140337, 082427140215, 082427130187, 082427130188, 082427130189, 082427130190, 082427130191, 082427130134, 082427250118, 082427250132, 082427040302, 082427040279, 082427040329, 082427020109, 082427020129, 082427020126, 082427020112, 082427020107, 082427230212, 082427230197, 082427230180, 082427230184, 082427230158, 082427230259, 082427230166, 082427230236, 082427230220, 082427050063, 082427110166, 082427110160, 082427100496, 082427100512, 082427100499, 082427100409, 082427100442, 082427100492, 082427100463, 082427100504, 082427100451, 082427100484, 082427100497, 082427100431, 082427100521, 082427100433, 082427100482, 082427160396, 082427160405, 082427160408, 082427160407, 082427160390, 082427160326, 082427160300, 082427160283, 082427160348, 082427160427, 082427160391, 082427160402, 082427160403, 082427160268, 082427160393, 082427180069, 082427030207, 082427120303, 082427120287, 082427120276, 082427120364, 082427120259, 082427120376, 082427120380, 082427120323, 082427120357, 082427120353, 082427120302, 082427120277, 082427120360, 082427120375, 082427120269, 082427120273, 082427120350, 082427200210, 082427200233, 082427200224, 082427200215, 082427200207, 082427070351, 082427070280, 082427070349, 082427070358, 082427070322, 082427070357, 082427070261, 082427090453, 082427090464, 082427090414, 082427090426, 082427090491, 082427090477, 082427090445, 082427090475, 082427090481, 082427090471, 082427140250, 082427140275, 082427140346, 082427140310, 082427140317, 082427140200, 082427140240, 082427140210, 082427170039, 082427210241, 082427210230, 082427210228, 082427210266, 082427210250, 082427190185, 082427190195, 082427190174, 082427290068, 082427150127, 082427150120, 082427150131, 082427150130, 082427240122, 082427030208, 082427030225, 082427030230, 082427220122, 082427220097, 082427220121, 082427220118, 082427310163, 082427310134, 082427310165, 082427310187, 082427310172, 082427310152, 082427010214, CY1028MR03, CS1006MR06, DK1547MR01, DK1547MR02, DK1549MR01, M4409455, 6786391, A1765918, M4018549, M4216469, M4017073, C21952103, M365865301, M4191127, M54807105, M1248634, M4040093, M41980120, M414406706, HC4929MR02, 360070MR01, PKOB02MR07, 624751MR01, H1039MR36, H1943MR23, 0828270058, HU1766MR01, 083027289269620, 083027008557723, 083027003625722, 083027001558421, 083027009590421, 083027006972719, 083027240825123, 083027241749522, 083027826696820, 083027286277319, 083027285275919, 083027204674620, 083027201983323, 083027280081224, 083027603507818, 083027043738521, 083027048505719, 083027805213421, 083027802798022, 083027009451123, 083027600149523, 7982MR0043, 7982MR0068, 7982MR0069, 7982MR0006, IE1111MR04, IE1038MR02, GON5446687, C5343136, A5105745, EM0256, EM0602, EM0601, EM0515, EM0513, MR00033, EM0509, EM0517, EM0923, EM0608, EM0606, EM0518, EM0929, MR00040, EM0919, EM0510, EM0600, EM0920, EM0615, EM0508, EM0317, EM0912, MR00006, EM0285, MR00136, MR00103, EM0607, MR00015, EM0504, EM0219, EM0928, EM0507, EM0512, EM0913, MR00071, EM0931, EM0511, MR00141, EM0906, MR00168, MR00169, EM0501, EM0506, MR00104, MR00185, EM0609, EM0514, EM0400, MR00021, EM0614, MR00124, EM0500, MR00077, EM0503, EM0245, EM0914, EM0502, MR00027, EM0908, EM0605, EM0611, EM0303, MR00228, EM0603, EM0203, EM0909, KA3300MR02, KA2801MR01, KA1139MR01, 0850270698, 0850270573, 0850270590, 0850270577, 0850270652, 0850270591, 0850270612, 0850270609, 0850270606, 0850270509, 0850270517, 0850270584, 0850270646, 0850270574, 0850270540, 0850270553, 0850270386, 0850270546, 0850270567, 0850270566, 0850270570, 0850270622, 0850270504, 0850270720, 0850270721, KW1010MR01, KW1013MR10, KW1013MR11, KW1100MR02, KW1008MR04, KW1008MR08, KW1011MR03, KW1005MR04, MR52661451, MR52661754, KW1155MR01, LV4001MR03, LB1160MR02, LB1001MR03, MRUA2042, MRUA2064, MRUA2408, 0920279031, 85110163303, 859MR000014, 85092252519, NO1012MR02, OM1007MR01, MRUA2219, MR8146PA, MRUA1416, MRUA2271, MRUA1314, MRUA1498, 1557MR0049, PL1398MR01, PL1111MR01, P00434MR01, 600092MR04, 600062MR01, PL1600MR01, PPS51801, PPS51802, PPS79500, PPS58406, PPR51811, PER19029, PPR96115, MRUA2257, QA1151MR02, MR50777961, MR53186271, RO1093MR02, RO1574MR01, RO1059MR04, RO1095MR02, RO1416MR02, RU6340MR03, RU1127MR04, RU9594MR01, RF3138MR01, RF1908MR03, RU1838MR04, RU7021MR01, RU1899MR01, RU2500MR02, RU2520MR01, RU9544MR01, RU1785MR02, RU3104MR02, RF0080MR01, RU1143MR03, RU1934MR01, RF3580MR01, SA1220MR02, SA1114MR02, SA5000MR06, SA5003MR03, SA1209MR02, SA1058MR05, 6073MR0052, 6073MR0020, ME645990, ME2083107, NPV64200, FEG88320, FEC800347, DE492A99, DED647165, DE6588189, DE2032127, DE5284117, DE528499, DPN26332, FE4438133, CEZ01560, MEX689444, DPN886102, NPD00400, YE645884, FP167513, NE419195, NEV439249, NPV64102, NPV64100, A004MR05, O009MR03, E001MR04, M001MR02, M004MR01, T002MR04, T002MR01, A020MR05, N002MR03, 850020MR02, 273354MR01, 529150MR01, 0850020MR02, 0853270220, 0853270201, 0853270218, 0853270214, 0853270192, 0853270223, 0853270202, 0853270212, 1573MR0042, 1573MR0024, 01002MRS04, 31020MRS01, 34492MRS01, 34418MRS01, 06051MRS02, 77624MRS06, 10044MRS05, 00132MRS01, 11187MRS01, 00023MRS01, 00020MRS04, MRUA0353, UZ1307MR01, 5973MR0074, 5973MR0056, 678342MR, 082427240126, 082427130197, 082427150141, 082427200219.

Distribution pattern

Worldwide distribution.

device · product 2 of 26

SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2460-2024
Recall number
Z-2460-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
956 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 520744MR, 714578MR1, RADNETMR1727, RADNETMR652, 951486MR2, RADNETMR651, 831RMGMR1, RADNETMR647, RADNETMR661, 720442MR, 303508MR, 860584MR3T, 203694MR3T, 860678MR3T, 860545MR3T, 860536MR3T, 203327MR3T, 860871MR3T, 203949MR3T, 305933MR1, 954489MR2, 954492MR1, 407ODMR3T, 863577MR, 863607MR, 386385MR1, 850696MR3T, 954423MR2, RADNETMR1700, 850877PNR, 706PIONEER, 847459MR, 815215FDMR, 217223BHMR3T, 217QMG3TMR, 574SBOPIONEER, 318769MR2, 504LCMCHMR, 985WCMR3, 508872PMR, 508998MR, 413SHMR3T, 508775MR1, 781331MR, 508756PMR, 410266MR5, RADNETMR1719, RADNETMR1713, RADNETMR1708, 443481MR, RADNETMR1720, 301279MR4, RADNETMR1696, RADNETMR1724, RADNETMR1695, 828250MRW, 704362PIO, 704384PIO, 704333PIO, 919471DDIMR, 910483CI3T, 336397P3T, 856532MR, 908735PMR, 201796MR2, 973301MR3, 732462MRPNR, RADNETMR1711, 856231MR, SDMIADPMR1, SDMINWPMR1, SDMIBDPMR2, SDMICR3TPMR1, 718596MR, 718245MR, 631CHSPNR, 631858MR, RADNETMR1702, 315792MR, 516NYCB3T1, 516NYCB3T2, RADNETMR1704, 716278P3T, 516766MR3T, 631751MR, 518926MR3T, 518880MR, 516340MR3T, 315SDMG3T, 716656P3T, RADNETMR1707, 610402MR3T, 4603875-MDF035-1-1-1, 864225MR3T, 843681BL3T, 843797ARTMR, 8435563T, 843234MR3T, 843777PL3T, 843777PIO3T, 864255MMR, 803936LMCMR2, SPORTSMED3T, 423553MRD, 972747EAMR, 361275PIONMR, 469648EOT3T, 214320DFWD3T, 214954PCDMR, 469902EFM3T, 817741ENFW, 817592ESFW, 817433PHMR1, 830HCMPMR, 972805ENFMR1, 972495TSGMR2, 713512MHMR1, MHNEMR1, 972258HAMR1, 281HMI750W, RADNETMR678, 832638SCMR1, 512APIRRMR, 210MSNWPMR, 817424TSSL3T, 801ENVBMR3, 801377MR6, 757578GE3T, 262289MR1, LXTPMSW1NET, LXTT15NET, LXTT43NET, 307733MR, MR5314AR, MR3048AR, MR6508AR, MR6802AR, MR6623AR, MR52800461, 83203735240, 83183534632, 83183547990, 83141851264, 83183543071, 83144557293, 83178104799, 834MR000002, 83183539988, 834MR000005, 834MR000006, 83132425984, 834MR000050, 834MR000021, 834MR000015, 83155846100, 834MR000013MM4, 83210367946, 83178782037, 83201375088, 83152240359, 833MR000024, 833MR000024MM4, 83199160995, 83170864668, 83153235400, 083027603871918, 083027600728323, 083027600259223, 083027600101122, 083027607448619, BY4197MR01, 190207MR01, 110009MR01, 150019MR01, 110059MR01, MRUA2341, MRUA2246, MRUA0897, MRUA0751, MRUA0592, MRUA1533, MRUA2387, MRUA1058, MRUA2091, MRUA1977, MRUA1479, MRUA0790, MRUA2067, MRUA1053A, MRUA1135, MRUA2262, MRUA2182, MRUA1761, MRUA1746, MRUA0774, MRUA1294, MRUA2012, MRUA2303, MRUA2342, MRUA1595, MRUA1721, BG4605MR01, 403253MR1, 250598MR1, MR2470CL, MRUA1674, 082427110150, 082427110108, 082427110148, 082427040339, 082427040219, 082427040202, 082427040245, 082427220133, 082427230246, 082427090424, 082427010211, 082427010142, 082427060114, 082427100458, 082427100420, 082427290066, 082427030188, 082427160345, 082427160277, 082427070336, 082427070237, 082427090336, 082427240106, 082427040260, 082427040234, 082427040211, 082427150102, 082427020100, 082427080114, 082427060086, 082427140324, 082427050050, 082427050048, 082427100387, 082427200211, 082427090368, 082427070341, 082427260011, 082427250078, 082427080090, 082427030161, 082427030184, 082427140204, 082427030154, 082427100416, 082427100419, 082427090454, 082427100357, 082427010204, 082427100422, 082427250087, 082427030193, 082427090397, 082427090346, 082427220128, 082427020095, 082427100365, 082427030147, 082427010161, 082427290065, 082427290072, 082427160194, 082427160338, 082427160306, 082427160264, 082427160395, 082427160398, 082427160363, 082427160294, 082427180086, 082427240107, 082427240075, 082427240089, 082427170033, 082427170047, 082427210168, 082427210200, 082427090369, 082427070269, 082427070328, 082427070333, 082427070334, 082427070221, 082427070326, 082427070250, 082427070291, 082427070228, 082427070192, 082427070302, 082427070259, 082427070220, 082427010206, 082427010167, 082427010213, 082427090377, 082427090374, 082427090382, 082427090360, 082427090383, 082427090340, 082427090355, 082427090332, 082427090339, 082427090353, 082427090399, 082427090348, 082427090412, 082427210206, 082427190193, 082427190199, 082427190177, 082427190153, 082427190186, 082427190162, 082427190182, 082427190160, 082427120256, 082427120252, 082427120257, 082427120234, 082427200183, 082427200175, 082427200229, 082427200222, 082427200109, 082427200220, 082427200177, 082427200162, 082427020115, 082427020076, 082427020114, 082427200178, 082427030195, 082427030227, 082427030175, 082427030174, 082427030137, 082427030157, 082427020128, 082427190205, 082427160267, 082427130120, 082427160314, 082427010181, 082427150116, 082427130141, 082427130118, 082427130114, 082427210190, 082427010157, 082427070298, 082427090388, 082427060094, 082427040256, 082427040244, 082427040209, 082427120239, 082427180055, 082427200200, 082427200152, 082427200142, 082427090357, 082427200179, 082427200202, 082427060105, 082427090404, 082427080105, 082427050062, 082427050052, 082427160332, 082427160248, 082427160231, 082427310136, 082427160261, 082427230133, 082427220074, 082427200161, 082427180083, 082427240114, 082427240112, 082427310156, 082427030201, 082427030164, 082427220091, 082427220092, 082427220093, 082427090349, 082427100370, 082427170044, 082427140208, 082427110163, 082427110164, 082427100389, 082427090440, 082427090379, 082427160259, 082427020105, 082427070260, 082427100360, 082427100329, 082427200184, 082427060100, 082427080109, 082427020078, 082427240109, 082427070265, 082427090372, 082427090342, 082427220078, 082427190170, 082427100369, 082427300030, 082427020121, 082427160254, 082427230149, 082427100379, 082427100381, 082427100372, 082427100401, 082427100479, 082427100356, 082427100402, 082427040312, 082427100421, 082427100519, 082427100441, 082427100363, 082427100485, 082427100473, 082427080087, 082427310173, 082427310161, 082427230186, 082427230250, 082427230256, 082427230169, 082427050053, 082427140314, 082427130119, 082427130116, 082427130103, 082427250111, 082427060108, 082427060084, 082427040233, 082427040242, 082427040243, 082427040253, 082427040229, 082427040218, 082427040330, 082427040252, 082427020092, 082427020093, 082427020130, 082427020132, 082427230181, 082427230240, 082427230128, 082427230183, 082427230219, 082427230188, 082427230223, 082427050057, 082427300039, 082427300040, 082427110167, 082427110141, 082427110105, 082427110142, 082427110146, 082427110149, 082427100507, 082427100474, 082427100412, 082427100315, 082427100444, 082427100380, 082427100502, 082427100375, 082427100477, 082427100411, 082427100515, 082427100413, 082427080083, 082427080099, 082427080082, 082427080141, 082427080102, 082427080101, 082427080096, 082427080106, 082427080136, 082427160372, 082427160305, 082427160335, 082427160321, 082427040306, 082427160260, 082427160237, 082427160365, 082427160253, 082427160389, 082427180088, 082427270070, 082427120231, 082427120240, 082427120245, 082427120304, 082427120289, 082427120243, 082427120219, 082427120359, 082427120285, 082427120266, 082427120320, 082427200221, 082427200128, 082427200208, 082427200129, 082427200159, 082427200141, 082427200232, 082427200154, 082427200206, 082427200186, 082427200176, 082427200185, 082427070321, 082427070243, 082427070315, 082427070270, 082427070206, 082427070222, 082427070297, 082427090356, 082427090447, 082427090391, 082427090411, 082427090466, 082427090442, 082427090451, 082427090398, 082427140207, 082427140279, 082427140319, 082427140299, 082427140318, 082427140327, 082427140334, 082427170046, 082427190171, 082427150139, 082427150118, 082427240097, 082427240083, 082427030159, 082427030186, 082427030152, 082427030176, 082427030132, 082427030197, 082427220103, 082427310120, 082427280028, MRUA2207, MRUA2366, MRUA2102, MRUA1732, FI1529MR01, FI1528MR01, 6630605, X868131018, M6013235, M4170017, M1220510, X151054618, 7893365, X832010008, M4186544, M523012201, 8124342, X180293403, 8477706, X70053501, B1020811, M2850024, M4201126, M6031213, X180555401, 6368777, GE1192MR01, UC1590MR05, 125528MR01, PC0127MR05, PC3741MR02, 477494MR02, 102207MR01, PC7479MR11, 164236MR01, 805466MR02, P00042MR02, 519659MR02, PC0396MR09, 158049MR01, TP0013MR01, PNUE04MR02, 157022MR01, 102208MR01, 262634MR01, PVIL01MR03, TP0008MR07, H1039MR59, H1349MR09, H12661MR01, MRUA2146, HU1573MR01, 083027001694718, 083027001004517, 083027249332422, 083027823408018, 083027800000000, 083027823888617, 083027828002316, 083027300000000, 083027206246319, 083027203606423, 083027217993720, 083027202667719, 083027219689319, 083027205107016, 083027204286118, 083027216245319, 083027287472616, 083027603021621, 083027049490119, 083027044418917, 083027804401220, 083027800993718, 083027809324716, 083027809620621, 083027841881218, 083027848334618, 083027843598318, 083027843057922, 083027029818718, 7982MR0035, 7982MR0052, 7982MR0018, 5512MR0020, 7982MR0025, 7982MR0046, 7982MR0015, 7982MR0042, 7982MR0037, 7982MR0028, 5512MR0023, 7982MR0010, IE1111MR02, A5248814, B5142305, A6012606, A5192422, A556284807, A5265815, 9734221, 9046395, A5129130, A5323816, A5811312, A5634625, A5383109, A5725519, A5328313, MR1938JM, ZC0318, ZC0302, ZC0015, ZC0037, ZC0306, ZC0002, MR00069, MR00070, ZC0003, MR00134, ZC0016, ZC0301, MR00115, ZC0020, ZC0001, ZC0305, MR00090, ZC0009, ZC0008, ZC0312, MR00081, ZC0038, MR00051, ZC0025, ZC0035, ZC0018, ZC0026, ZC0304, ZC0012, ZC0007, ZC0006, ZC0315, ZC0010, ZC0011, ZC0021, ZC0004, ZC0027, ZC0028, ZC0014, ZC0030, ZC0034, ZC0307, ZC0013, ZC0022, ZC0309, ZC0017, MR00025, ZC0029, ZC0019, ZC0319, ZC0308, ZC0313, MR00151, ZC0314, ZC0024, ZC0032, MR00080, ZC0036, ZC0031, ZC0023, ZC0033, ZC0303, MR00046, KE6280MR01, 0850270796, 0850270773, 0850270699, 0850270615, 0850270582, 0850270764, 0850270731, 0850270681, 0850270702, 0850270795, 0850270740, 0850270713, 0850270579, 0850270587, 0850270585, 0850270707, 0850270610, 0850270603, 0850270583, 0850270529, 0850270512, 0850270486, 0850270700, 0850270623, 0850270624, 0850270535, 0850270717, 0850270640, 0850270690, 0850270655, 0850270638, 0850270632, 0850270608, 0850270621, 0850270489, 0850270778, 0850270710, 0850270706, 0850270599, 0850270488, 0850270657, 0850270547, 0850270629, 0850270530, 0850270659, 0850270631, 0850270687, 0850270688, 0850270597, 0850270605, 0850270762, 0850270722, 0850270724, 0850270715, 0850270662, 0850270661, 0850270626, 0850270580, 0850270753, 0850270581, 0850270539, 0850270784, 0850270780, 0850270804, 0850270793, 0850270561, 0850270752, KW1100MR03, MR52182291, LB1040MR03, LT4111MR01, LT4124MR01, MR52002481, MR52630931, MR52692081, LT4079MR02, MC1024MR02, 1553MR0015, 1553MR0025, MRUA2360, MRUA2351, MRUA2359, MRUA1070, MRUA2353, MR53818491, 6073MR0023, OM1011MR02, MRUA0646, MR1881PY, 1557MR0038, 1557MR0021, P00021MR01, P00007MR03, PL1751MR02, PL1692MR01, PL3811MR01, PER00497, PPS39214, PPS17604, MRUA1939, RO1115MR02, RO1686MR01, RO1681MR01, RO1547MR01, RO1205MR02, RO1046MR01, RO1669MR01, RO1568MR01, RO1642MR02, RO1508MR04, RU3563MR01, RF0066MR01, RU3508MR02, RF2612MR01, RU1282MR02, RU3356MR01, RU1516MR02, RU1834MR03, RF1085MR01, RU0301MR01, 600100MR05, RU1449MR02, RU1463MR02, 600105MR02, RU2592MR01, RU0680MR01, SA1133MR01, RS4156MR01, ZA2240MR02, ZA3171MR01, NPV27710, YP158330, MPX57800, NPV73518, FPD24003, CE270967, MPX43810, DPN62303, DPD15901, MPX39941, MEX61793, MPX60700, CPM80623, MP842036, FPG30548, NPV15985, O012MR02, N006MR03, 899010MR04, 529170MR02, 160886MR01, 0899010MR04, 265050MR05, 724010MR05, 697040MR02, 146806MR01, 121497MR02, 501032MR01, 167187MR01, 334963MR01, 779205MR01, 725030MR02, 259200MR02, 222768MR01, 115030MR02, 0853270195, 0853270167, 0853270203, 1573MR0010, 1573MR0041, 1573MR0028, 1573MR0060, TN2000MR01, 06048MRS01, 06184MRS05, 06184MRS01, 06184MRS04, 16039MRS02, 41053MRS01, 34340MRS02, 34173MRS02, 34026MRS05, 35117MRS01, 33044MRS01, 09004MRS01, 34185MRS02, 34225MRS02, AE1190MR02, AE1149MR01, 11073MRS01, 11161MRS01, 10627MRS02, 77990MRS01, 00313MRS02, MRUA1991, 5973MR0021, 5973MR0044, 5973MR0030, 5973MR0048, 5973MR0038, 5973MR0017, 5973MR0033, 5973MR0102, 5973MR0108, 5973MR0008, 5973MR0046, 5973MR0013, 5973MR0084, 0850270802, VNMR54372061, 082427130204.

Distribution pattern

Worldwide distribution.

device · product 3 of 26

SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2461-2024
Recall number
Z-2461-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
96 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 501225HEROMR3, 480425MR12, RADNETMR665, 719293MR, 719505MR, RISMR, 678604PHMR, 217258SBMR3T, 508258MR, 406327AMR2, 336760MR2, 402AMI3T, 585922HEROMR, 405601MR2, 843MSEA3T, 713SIGNAHERO1, RADNETMR677, 903758MR3T, 713442KSMR7, 713442FTBNDMR2, 361572HERO, 703797MR1, 832MR000038, 834MR000043, 835MR000031, MR52991481, 083027602496623, 019022MR04, MRAR0023, MRAR0053, 6073MR0059, MRAR0073, MRAR0102, 9668457, 9663364, 8133338, 7361386, 7272696, 7302598, 8425694, 8880017, 6364869, PC2007MR04, H1066MR45, H7270MR01, 083027218333223, 083027807459324, A119731011, A139569302, MR00164, MR00193, MR00194, MR00146, MR00147, MR00182, MR00250, MR00137, MR00183, MR00252, MR00165, MR00247, MR00184, MR00227, 0850270781, 1553MR0067, MRAR0080, MRAR0060, 6073MR0054, DP461335, DPN80004, MP3249110, 849010MR04, 0849010MR04, 222769MR01, 169213MR01, 168934MR01, 752030MR04, 120928MR03, 529150MR03, 529150MR04, 529150MR05, 750100MR04, 1573MR0075, 10197040, 8328819, 7974368, 5973MR0092, 5973MR0082, 5973MR0110, 704384HERO, 083027603761824, GON5452693, MR54353681, MRAR0184, VNMR54373121, RADNETMR1730.

Distribution pattern

Worldwide distribution.

device · product 4 of 26

SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2462-2024
Recall number
Z-2462-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
404 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

205934MR1, 205750MR2, 205345MR3T, SMIROMEPREMMR1, SMIGDYPREMMR1, 602830MR3, 602406MR6, 520UNCMR1, 510STPRMR, 858657MR6, 858657MR5, 858657MR4, 858657HDMR3, 661949MR3T, 510MIA3T, 415723CHMR7, 415493VMR3, 415723SHMR17, 415723SHMR14, 650723SSMR2, 650723NCMR1, 650723NCMR2, 415UCWNMR1, 415UCWNMR2, 415CBPR2, 415353UMR2, 415PCMR1, 415PCMR2, 415CBPR, 415MB3T, GON5236887, 415723SHMR18, 650723SSMR1, 925JMPMR1, 925JMPMR2, 719595MR, 860545PREMIER1, 203855MR3T, 561297MR1, 904996MR3T, 850475IC3T, 813979MR1, 4043503TMR, 770965MR1, 770965MR2, 515643MR3T, 319335MR3, 319335MR2, 708LOYMR3, 309353PMR, 309672MR3T, BWHMAGNUS007MR, LONGWOOD30MR2, 617754MR5, 617754MR4, 617887MR, ALLIANCESIG468, 781487MR3, 781487MR4, 508831MR1, 734845VA750MR, 313593MR3T, 313916PREMIER2, 313916PREMIER, 3137453TMR, 269341MR3T, 269342MR3T, 269DVMR, ALLIANCESIG498, 248551MR3T, 734246PREMIER, MR1046093, MR1004373, MR1004371, MR129033, MR1004367, MR229064, 573815BMR1, 662841MR4, 828213MR, 910609CF3T, 252VMC3T, 336718MR1, 603952MR2, 7326133T, RADNETMR1714, HSSWSMR750P, NEUROMR4, NEUROMR1, NEUROMR2, NEUROMR3, MSKDHKMR2, HSSMAGNETJ, MSK68MR03, MSK68MR02, 212543PREMIER, MSK68CIGIMR2, HSSMAGNETG, MSK65MR1, SINAI750MR, 212305MR83T, 585275PREM3T, 5853413TLAC, 516HSSMR3T, 216791MRPREM, 419383MR3T, 918397MR, 405634S3T, 610740MR3, 401444MR3T, 6053383TMR, 6053223TMR, 901287MR3T, 972497BSFMR, 713792AMR18, 713799TOMR1, 713792AMR16, 832522MR1, 713441MR8, 713441MR9, 513556MR, 713704HMR4, 801IMCPREM, 703573PRE1, 703573PRE3, 70389MR3T, 8047643T, 703478MR5PRE, 8043303T, 425297RMR, 206288SCCMR, 509474SH3T, 715839MR3T, 608UWVCMR, 608262WIMRMR1, 608RIOMR1, 608WIMRMR2, 414955MR3, 608392PREM, 837MR000016, 220078MR02, 210036MR03, BA4080MR01, BAMR51245761, 2854971, 2558948, 905540MR3T, 514934MR4, 082427110133, 082427040278, 082427040282, 082427040258, 082427220102, 082427120358, 082427010199, 082427010185, 082427140305, 082427250117, 082427140297, 082427140296, 082427120354, 082427140226, 082427310175, 082427310142, 082427090498, 082427090430, 082427060093, 082427220109, 082427190156, 082427100495, 082427160278, 082427160413, 082427180062, 082427170045, 082427210246, 082427120370, 082427120286, 082427120355, 082427120365, 082427040298, 082427160412, 082427140285, 082427130181, 082427130153, 082427160424, 082427090482, 082427130175, 082427130146, 082427130157, 082427130164, 082427130151, 082427130152, 082427040319, 082427040277, 082427040228, 082427250139, 082427160340, 082427160329, 082427230232, 082427040301, 082427140342, 082427140268, 082427230263, 082427190187, 082427100490, 082427280033, 082427130150, 082427100509, 082427130174, 082427130145, 082427310176, 082427050055, 082427140329, 082427130170, 082427250103, 082427250123, 082427040259, 082427040324, 082427040337, 082427040336, 082427040295, 082427040322, 082427040311, 082427040290, 082427230233, 082427230228, 082427230195, 082427230200, 082427230191, 082427230190, 082427230248, 082427230267, 082427230227, 082427230157, 082427230193, 082427110143, 082427110162, 082427110120, 082427080146, 082427160350, 082427160357, 082427160414, 082427160415, 082427120328, 082427120379, 082427120352, 082427120346, 082427200189, 082427200217, 082427200168, 082427140274, 082427140283, 082427140295, 082427140294, 082427140325, 082427140328, 082427170037, 082427170040, 082427190188, 082427290050, 082427150119, 082427240117, 082427030214, 082427220143, 082427220106, 082427220125, DK1083MR04, DK1044MR05, DK1566MR01, MR51991391, FI1003MR04, S41600123, S41600164, M4016047, M1446012, A62925715, 6132498, X1617002, N4192951, 6910129, M54606125, M4152248, M345477701, 7401992, 6237185, M5484960, M40345186, 8074990, C4200438, M2322268, H4858990, M4215566, 6461558, M45052106, HC1627MR04, 353745MR01, 493013MR01, UC1559MR01, UC1559MR02, 615010MR02, H10392MR03, H17641MR27, 0828270064, 0828270080, 0828270082, 083027207526721, 0835270017, IL1062MR07, A5158832, A5108257, A5278407, B5129925, A51529238, EM0610, EM0922, MR00112, EM0613, EM0604, MR00123, EM0916, EM0030, EM0910, EM0612, EM0927, MR00038, 0850270708, 0850270775, 0850270786, 0850270776, 0850270756, 0850270754, 0850270718, 0850270719, 0850270658, 0850270650, 0850270799, 0850270792, 0850270794, 0850270800, KW1004MR09, 0834270010, 56MRE3TH2565370, 570844HCM3T, MR3T2600554, RTD01204, 85205055862, 0920279028, NO1011MR04, NO1005MR02, OM1042MR01, PPS51873, PPR88681, RU1086MR06, RU8554MR01, RU1018MR02, SA5000MR03, SA1012MR07, SA1054MR05, 6073MR0055, SK1056MR02, SK1064MR01, SK1121MR01, FPG98441, GEE34040, DEH135103, DPN88672, O005MR01, K002MR03, E001MR05, T002MR03, A210MR02, A229MR01, A203MR02, A203MR03, A203MR01, AC001MR03, 475290MR03, 120810MR02, 222768MR03, 121351MR02, 123953MR01, 541010MR04, 1573MR0051, 1573MR0045, 34461MRS01, 35096MRS01, 34006MRS03, 70001MRS14, 00001MRI01, 00243MRS07, 9789185, 00130MRS05, 10307MRS03, 70043MRS07, 10050MRS04, 70431MRS05, 00269MRS04, 70328MRS06, 70065MRS04, 9830MR0116, 083027002949924, 11774567, 11524261, YM1801.

Distribution pattern

Worldwide distribution.

device · product 5 of 26

3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System

Z-2463-2024
Recall number
Z-2463-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 907562P3T, 205939MR4, 2059393T, 256734MR3T, 623879MR1, 623433MR1, 928213MR3T, 928223MR3T, 480584MR1, RADNETMR656, 602588CMR1, RADNETMR670, 602689MR1, SMIGDYMR1, 9287573TMR, 480464MR1, RADNETMR669, 480324MR1, 4809643TMR, 954SIMON3T, 4802643TMR, 480478MR1, 831423MR, 480264MR2, 480425MR5, 480614MR1, 928317MR1, RADNETMR590, 310623MR, 714868MR1, 626359MR3, 760ENCMR, RADNETMR615, 714619MR, 5107923TMR, 858657MR1, 213777MR, 213387MR, 323268MR2, 323442MR3, 213977MR2, 323442MR1, 323442MR2, RADNETMR612, 650259SM3T, RADNETMR1521, RADNETMR592, 805GI3T, RADNETMR1716, 760323MR3T, 650FALK3TMR, RADNETMR617, 626397MR2, RADNETMR620, RADNETMR646, 909806MR, 916DR3TMR, 916KM3TMR, 916UCDMR3T, 415600D3T, RADNETMR1595, 408885MR3T, 408GS3TMR, RADNETMR608, 805569MR, RADNETMR1706, 661AIMR2, RADNETMR594, 510939JMMR3T, 626962MR, 805CHLIMR1, 303SMIMR1, 303633MR, 970244MR3T, 720SMLITMR3T, 719542MR, 203863MR3T, 202865MR3T, 3173383T1, SIMONMED3TBRANDON, 407OSCMR3T, 239307MR, PRMTMR3T, 727440MR1, 030022MR01, 412692MR1, 813972MR3T, 813251MR3T, 772VRAMR3T, 7067213TMR, 808591MR, 3096653TMR, 847SAMC3T, 708383WS3T, 859275MR3T, 2709263HD, 225763MR, 504873TMR3, 504DISMR3T, 504DISWMR, BEV3TMR, 9786823T, RADNETMR1659, RADNETMR1589, 301459MR, 269342MR3T2, 517374MR3T, 248465MR3T, 248849MR3T, 2489643T, 662MSU3T, 406751K3T, 402219MR3T, 908725MR, 609652MR3T, 732223MR, 609497MR3T, 201669MR2, 919684MR3, 7024230SM3THL, M48823, COR373219, 716859MR3T, RADNETMR554, NYP347652, 5857853T, 631686MR3T, RADNETMR1583, 405CDIMR, 503216MR3, 503215MR1, 717975MR3, 6109883TMR, 423553MR750, 731935MR3, 865218MR3T, 865541MR3T, 901572L3T, 615777MR3T, 615284MR3T, 615TANMR, 865481MR3T, 865545MR3T, 936441MR1, 512TSIMR2, 214341PDGPMR1, 713524BIMR1, 346335MR, 713441MR5, 346SMKFWMR, 210617TCAMR2, 346SGLD3T, 801373MR3, 435688MR3, 540776MR3, 2063203TMR, 414973MR2, 414973MR1, 16683THDX, 2901847MR3T, 422SIGNA3T, 0910272046, 2885417, 2871974-1, 2723694, 2644266, MRWB0540, 2550000, 416369MR3T, 604739MR, 082427110026, 082427110034, 082427110027, 082427040147, 082427270030, 082427010074, 082427070062, 082427160117, 082427140062, 082427140120, 082427010093, 082427150048, 082427060028, 082427190069, 082427010047, 082427150051, 082427290013, 082427160084, 082427160103, 082427160110, 082427240019, 082427240070, 082427170008, 082427210070, 082427210127, 082427070120, 082427070101, 082427010041, 082427010054, 082427010038, 082427010095, 082427010069, 082427010150, 082427090190, 082427090170, 082427090292, 082427090335, 082427090245, 082427090124, 082427090267, 082427090263, 082427090238, 082427090232, 082427090208, 082427090173, 082427010077, 082427090227, 082427090226, 082427090134, 082427210053, 082427190049, 082427190078, 082427190075, 082427120201, 082427120102, 082427120091, 082427120199, 082427200052, 082427020041, 082427120083, 082427030116, 082427030090, 082427040149, 082427170012, 082427130059, 082427130090, 082427130046, 082427130044, 082427160081, 082427160105, 082427040113, 082427040101, 082427040080, 082427120070, 082427200056, 082427200036, 082427110042, 082427020037, 082427060051, 082427250060, 082427030106, 082427080026, 082427090164, 082427160113, 082427160159, 082427070055, 082427120077, 082427250088, 082427020025, 082427310046, 082427030050, 082427150056, 082427100126, 082427160072, 082427140067, 082427140077, 082427110047, 082427100164, 082427070063, 082427150103, 082427200072, 082427310048, 082427310108, 082427240041, 082427240030, 082427090141, 082427060034, 082427240034, 082427010065, 082427060063, 082427060032, 082427060025, 082427300018, 082427100102, 082427100198, 082427100182, 082427100201, 082427100173, 082427100172, 082427100153, 082427100228, 082427100185, 082427100119, 082427100309, 082427130084, 082427130062, 082427080051, 082427310032, 082427310029, 082427270016, 082427270040, 082427270032, 082427060038, 082427230068, 082427300012, 082427110044, 082427100161, 082427100192, 082427100176, 082427080044, 082427160064, 082427160203, 082427160272, 082427120086, 082427120093, 082427120072, 082427200039, 082427070054, 082427070116, 082427090174, 082427090246, 082427090171, 082427090288, 082427090229, 082427140051, 082427210060, 082427190066, 082427240048, 082427030115, 082427030071, 082427030086, 082427030056, 082427220018, 082427310034, CY1245MR02, DK1564MRMR, DK1576MRMR, DK1523MRMR, ET1009MR01, MC6946MR07, H2193MR05, 083027006495511, 083027002730811, 083027009445910, 083027007755738, 083027002101567, 083027202101396, 083027207848338, 083027041002010, 083027024220111, 083027022101691, 083027609389015, 083027605826311, C5323526, A5632416, MR3014JM, YM1799, YM1840, YM1816, YM1882, YM1810, YM1870, YM1411, YM1849, YM1848, YM1404, YM1261, YM1839, YM1851, YM1837, YM1797, YM1794, YM1798, YM1819, YM1844, YM3900, YM1827, YM1824, YM1793, YM1402, YM1792, YM1818, YM1846, YM1880, YM1881, YM1842, YM1788, YM1834, YM1813, YM1850, YM1823, YM3939, YM1843, YM1879, YM1826, YM1847, YM1395, YM3883, YM1815, YM1400, YM1831, YM1832, YM1821, 0850270333, 0850270220, 0850270202, KW1004MR03, LB1000MR02, MR281340MR0, 2887688HDXT30T, PL3800MR01, PL3040MR01, PL3546MR01, PER19516, PER28007, PER08626, RU1095MR03, RU1089MR04, RU1884MR01, RS4202MR01, SI4024MR02, ZA2169MR01, ZA2222MR01, GP178328, MPX82251, DEL26444, CEN03406, DPC79014, DEN51500, MEX68900, MPX10000, ME051580, EPP00302, G002MR01, SY2012MR02, 0853270094, 11725MRM02

Distribution pattern

Worldwide distribution.

device · product 6 of 26

Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2464-2024
Recall number
Z-2464-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
484 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 205592450W, 205592750, BMDACCMR1, 480425MR6, 623SMCSMR, 602839MR1, 602RITMR, 480768MR2, RADNETMR644, UCB3TMR, 3106573TMR, 650PH3T, 760SMCBMR, 510537MR750, 559325CIIMR3, 858822HDMR3, 858822HDMR1, 209225VC750, ASLW750, 415723CHMR3, 415723SCHMR2, 415493VMR2, 415723CHMR2, 650780MR750, MDF013-1-2OS0CA8W, RADNETMR645, 916LST3TMR, 858939MR5, 858249HLIMR1, MDU009-GE13+4242063+5P1, 415UCBHMR2, 415UCBHMR1, 415OI3TMR, 415L3TMR1, 415L3TMR2, 408358SHMR13, 805687MR1, 415723SHMR19, 415723SHMR21, 415723SHMR16, INSIGHTMR3228, 303699MR2, 720321MR, 202476MR3, 302744MR750, DUPONT3T, 386FMR3T, 561495MR1, 954772MR1, 904202MR9, 904SM3T, 863688MR, 727698MR17, MUNROEMR, AUI3T, 850494450W, 850RA450W1, 813972VAMR, 706UGA3T2, 515222MR1, 847618MR1, 312355DVMR, 312996MR3T, 708349DVMR, 309683MNMR750, 217223BHMR, 630CDH3T, 765494MR750, 617726MR1A2, 301295MR3DV, 301496MR3T5MR, 301295CRADA, 301295MR3T2, 301295MR4, 301496MR3T6MR, 240296MR3T, 202476MR4, 207945MR750, 7347633TMRFIX, UM750MR, 810235DVMR, 6162673T750, 616494DVMR, 2486613TMR, MR129037, MR129035, MR129034, MR129030, 816698CP3T, 816932DVMR, 704384DVMR, 910907WAMR1, 6036503T, 732262MRGS, 201634MRW, 7168453T, CORT450W, 607CORNELL3T, CBCIMR750, MSK65MR2, MDU018-1-2Q5XBKV2, MDU018-1-2Q5XBKZP, HSSMAGNETC, 585785MR750, 614722MR3, 405752I3T, 918491MR2, 541CMRIMR, 503331MR1, 570271MR6, 412623MR1, 412647PUHMR1, 615MTMR1, 4192142MR91, 713792AMR17, 713566SMITH2, 713792CMR1, 281477MR2, 713441MR7, 210LAFB750, 210614MR1, 281274MR1, 281276MR750, 903525MR750, 801377MR3, 801268MR2, 434UVAMR, 703573DV4, 703391MR2, 703805MR3DV, 540MIF3T750, 7579533T, 804675VA3T, 540665MR3T, 425750PMR, 206762VAMR, 206320CH450W, 206CH750MR, 509473DMR3T, 715838MR3T, 608417MR1, 608890MR750, 608HERIMR, 608262RP4, 414805MR4, MRUA0136, MRUA0343, MRWB0843, 1063THDX, 0910272071, 0910272072, 0910274032, 83096322711, 83160776416, 110028MR01, 2706164, MRUA0272, MRHM0942, MRUA0447, MRWB0558, MR13905YR5, 2875893, MRHM1586, MR13708YR3, 2744287, 2655437, 902473MR2, 905522MR3T, 519685MR3T, 514848MR1, 416595MR1, 604875MR750, 082427110049, 082427040163, 082427040199, 082427040187, 082427040155, 082427040153, 082427040154, 082427040143, 082427040123, 082427040151, 082427040141, 082427040224, 082427040157, 082427220040, 082427040148, 082427140107, 082427010056, 082427080068, 082427100184, 082427160114, 082427250070, 082427140176, 082427310077, 082427160118, 082427100311, 082427110080, 082427090169, 082427060042, 082427240082, 082427210226, 082427150073, 082427150075, 082427150058, 082427150077, 082427160128, 082427290031, 082427160151, 082427210136, 082427070075, 082427070176, 082427070212, 082427070079, 082427010073, 082427090241, 082427090298, 082427090269, 082427210068, 082427190118, 082427120141, 082427120107, 082427120132, 082427120145, 082427120101, 082427120092, 082427200076, 082427200110, 082427020075, 082427020039, 082427030127, 082427030100, 082427030076, 082427210116, 082427230051, 082427140106, 082427140076, 082427130089, 082427130078, 082427030092, 082427310062, 082427130079, 082427130080, 082427130075, 082427130072, 082427130096, 082427290023, 082427230106, 082427040205, 082427040249, 082427040208, 082427040180, 082427040177, 082427040189, 082427040174, 082427040166, 082427040172, 082427040165, 082427040137, 082427040133, 082427040132, 082427040127, 082427040120, 082427040119, 082427040116, 082427120150, 082427180027, 082427200058, 082427150070, 082427150047, 082427110084, 082427020042, 082427010081, 082427050037, 082427050034, 082427050028, 082427110058, 082427090283, 082427160129, 082427160088, 082427090201, 082427120097, 082427140130, 082427180031, 082427180029, 082427180022, 082427210121, 082427030094, 082427150090, 082427100215, 082427170029, 082427160239, 082427140098, 082427100223, 082427100339, 082427100335, 082427150082, 082427140122, 082427210081, 082427310057, 082427120129, 082427090308, 082427090311, 082427090261, 082427090148, 082427020056, 082427190111, 082427100319, 082427090256, 082427060106, 082427260005, 082427080053, 082427230048, 082427100202, 082427100235, 082427100326, 082427100256, 082427100229, 082427100213, 082427100149, 082427100270, 082427100318, 082427100274, 082427080061, 082427310091, 082427310084, 082427050033, 082427050029, 082427010094, 082427270045, 082427270050, 082427270064, 082427270037, 082427260003, 082427140116, 082427140125, 082427140229, 082427130087, 082427130066, 082427050043, 082427040168, 082427040128, 082427040184, 082427040161, 082427040150, 082427040183, 082427040114, 082427040121, 082427040144, 082427040142, 082427020059, 082427020036, 082427310137, 082427300019, 082427110045, 082427110059, 082427100291, 082427100241, 082427100333, 082427100279, 082427100244, 082427100251, 082427100147, 082427100284, 082427100231, 082427080062, 082427160205, 082427160212, 082427160193, 082427160101, 082427160211, 082427120174, 082427120172, 082427120133, 082427120179, 082427200114, 082427070230, 082427070137, 082427070204, 082427090317, 082427090309, 082427090291, 082427090202, 082427140094, 082427140123, 082427140087, 082427140113, 082427140112, 082427210111, 082427210130, 082427190099, 082427150062, 082427150111, 082427030120, 082427310059, 082427010128, 082427010111, 082427010072, 600110MR01, DK1047MR06, EG1000MR03, EG1793MR01, EE4019MR02, UC2547MR01, PC7479MR08, RMUE01MR03, 615010MR01, H10645MR17, H41224MR01, R83027604627124, IL1020MR04, A5279314, A5820844, F5119155, A51152177, A5634737, B51142110, EM0003, EM0001, EM0021, EM0026, EM0002, EM0017, EM0015, YM1397, YM1396, EM0016, EM0005, EM0020, EM0022, EM0023, EM0009, EM0019, EM0006, EM0018, DMY002, DMY001, EM0004, EM0025, EM0007, EM0014, YM1790, KE9005MR01, 0850270367, 0850270370, 0850270341, 0850270423, 0850270351, 0850270197, 0850270377, KW1102MR01, 030013MR02, MR303872MR6, MR302922MR0, 81MR3T2715363, AMS0424, NO1011MR01, P00007MR02, PL2853MR01, PPS20810, 787740MR3T, MR16061YR4, RU3508MR01, RU1086MR03, SA2180MR02, SA1012MR02, CPZ43623, FPG46809, K002MR02, 786090MR06, 690120MR01, 0853270111, 0853270104, 0853270103, 0853270109, 0853270117, 0853270118, 0853270119, 0853270125, 70001MRS11, 10197MRS03, 70043MRS05, 00040MRS01, 70383MRS05

Distribution pattern

Worldwide distribution.

device · product 7 of 26

Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2465-2024
Recall number
Z-2465-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
724 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 9075653T, 2059953T, 2567373T, 251639MR3T, 334273CIC750W, 479571MANA, SMIDOB750W, 602863MR, 480265MR1, 480342MR3, SMIMCK750W, RADNETMR597, 530CHI750W, 840200DVMR1, 562869DVMR, 916V53TMR, 657293MR1, 949777MR1, 858824MR1, 858622HDMR1, 562826MR2, 213223DVMR, 408356MR1, 310554DVMR, RADNETMR599, 949760MR3, 510449MR750W, 805779MR3, 619543HDMR4, CALPAC750, 415SLMR750, 415UCBHMR3, RADNETMR613, 415CB3TW, 310264MR2, 415723SHMR20, 415723SHMR12, 805434MR3, 310802DVMR, RADNETMR621, 559734VIMR1, RADNETMR598, 720848MR4, 303492MR, 720854MR, 719255MR, 719365MR, 303837MR2, 970764MR, 303788MR6, 3034682202MR, 303604MR2, 970624MR1, MDF020-1-2665NP18, 303577DVMR2, 856247MR3, 860446MR750W, 202966MR3TW, 302430MR750W2, 302430MR750W, 561955MR1, 561497MR1, 954355MR750W, 904202MR12, 904483MR3T, 561844MR1, 305665MR750W, 386FNSBMR3T, 407SMSLMR1, 386FHPCMR3T, SMWP3MR, 706787750DV, 706291RMR2, 671NAVYMR, 671FHPMR750W, 808485MR2, 808HRAEMR750W, 808545MR, 808873MR750W, 312702PMR, 7737923TMR, 312702MR750, 773665SJMR2, 217876DMH3T, 630275GS3T, 630833ELM3T, 847316MR3T, 815300MR2, 708346MR4, 708346MR3, 708747MR, 217562PANAMR, 1000004828, 1000004987, 815968MR, 1000004288, 708444DVMR, 847872ZMR2, 219865MRI, 260266750W, 317887MR3, 317865MR4, 913588NMRW, 913322MISHMRW, 913491MR750W, 859334MR, 270798MR2, 502255MR3T, 318443MR2, 225763MR2, 337289MR1, 504TULMR3, 337943MR1, 617754MR7, BOSTONMEDMR1, 508746MR3, VAWESTROX750W, RADNETMR1651, 410328MR3T, RADNETMR1635, RADNETMR1629, RADNETMR6066, 3014643TMR, 240420750W, 240707MR3T, 301570MR, RADNETMR1662, RADNETMR6073, RADNETMR1652, 410546MR3T, RADNETMR6071, RADNETMR1686, 248533750W, 616267IMRI, 616774MR750W, 763795MR1, 507385MR3T, MR229049, MR229055, MR229054, MR229050, MR229047, MR229048, MR229046, 636933M3TMR, 314577CGMR3T, 6033343TW, RADNETMR1631, 856537MR, RADNETMR1632, MNMR01, 856581MR3T, 973971MR750W, 732776MR750W, 856247MR1, 702382MR750W, RADNETMR1687, 718234MR, 7182005MR, 718854MR, RADNETMR1648, 71872MR750W, EAST750W, 212288MR4, 21277MR1, 716740MR1, 585266MR3T, RADNETMR1639, 914631MR, 914750W, 914288MR3T, 330344MR750W, 6142343T, 937208MR1, 419251MR3T, 405636SMR2, 405271OUCMR, 503251PMR3, 215FCCCMR3T, PRESBYMR1, 412692OR750W, 843815750W, 843750WGEM, 864529MR, 865984MR750, 423493MR750W, 423478MR3T, 615791OP3T, 423472MR3T, 512TSIMR3, 512544SD3T, 214433TN750WMR1, 214820TS750WMR, 2148203TMR, 214645UT3TMR1, 9157473TMR, 817225EBIMR1, 817433HSWMR2, 409772IMRISURG, 409772MR6, 713MOCMR750, 281333MR2, 713792AMR14, 713798MR1, 210WHASCMR1, 713363MR750, 972395EPMR1, 210AMVAMR, 210617HUBMR, 281WLMR1, 903525MR750W, 801377MR5, 801ENVMR, REVERESGMR1, 435251MR1, 434MJMR2, 703698MR4, 757827MR2, 757388750WMR, 757889750WMR, 703478MR2DV, 757673DVMR, 757983MR, 206223VM750W, 206781SB750W, 206320CH750W, 206292SR750W, 509363PMPMR, 920738MR750, 608775MR3T, 414805IMR1, 414649WB2, 414647MR1, 715847MR3T, 307BHBBJ3T, DZ1638MR01, DZ1060MR04, MR7375AR, 83096535911, 83108956002, 83096536248, 83104653897, 0910274040, 0910273043, 83144839290, AP7645MR01, BH1017MR01, BY4160MR01, 441239MR750W, MRUA0467, MRUA0589, MRUA0191, MRUA0499, MRUA0566, MRUA0122, MRUA0328, MRUA0887, BG4680MR01, 403229MR1, 613737MR1, 082427110129, 082427110094, 082427110097, 082427110068, 082427040194, 082427040139, 082427220057, 082427100378, 082427120218, 082427100358, 082427030150, 082427110135, 082427010126, 082427060065, 082427040236, 082427040195, 082427040190, 082427210129, 082427120213, 082427120189, 082427150117, 082427150087, 082427150083, 082427010080, 082427010087, 082427080074, 082427140144, 082427310090, 082427160149, 082427120193, 082427140124, 082427210174, 082427160346, 082427110091, 082427100331, 082427100287, 082427100265, 082427100336, 082427180035, 082427120210, 082427120180, 082427150099, 082427310119, 082427240077, 082427090413, 082427190105, 082427150114, 082427160233, 082427160301, 082427290032, 082427160324, 082427160299, 082427160220, 082427160244, 082427160275, 082427160218, 082427160162, 082427160221, 082427160166, 082427180037, 082427240081, 082427240054, 082427180028, 082427170024, 082427170020, 082427170022, 082427210199, 082427070157, 082427070175, 082427070177, 082427010109, 082427090330, 082427090284, 082427090300, 082427090273, 082427210156, 082427210149, 082427210118, 082427120159, 082427120110, 082427120204, 082427120194, 082427120149, 082427120135, 082427120176, 082427120154, 082427120136, 082427120116, 082427200113, 082427200092, 082427120170, 082427200104, 082427030134, 082427130108, 082427130098, 082427130092, 082427110090, 082427160158, 082427040232, 082427040198, 082427040200, 082427040146, 082427040135, 082427120175, 082427180047, 082427180046, 082427200140, 082427200122, 082427200103, 082427150093, 082427110051, 082427200086, 082427080094, 082427120203, 082427230129, 082427120186, 082427120168, 082427120160, 082427120181, 082427120184, 082427120173, 082427140133, 082427210169, 082427100349, 082427120131, 082427120122, 082427320002, 082427190142, 082427190130, 082427230108, 082427160178, 082427010171, 082427060052, 082427280024, 082427100267, 082427220052, 082427080089, 082427080080, 082427100303, 082427100219, 082427100271, 082427100254, 082427100246, 082427130076, 082427100323, 082427100225, 082427130143, 082427130101, 082427130099, 082427100320, 082427080095, 082427310101, 082427310087, 082427080063, 082427250061, 082427140154, 082427140225, 082427140162, 082427130097, 082427250066, 082427250056, 082427250076, 082427040173, 082427040197, 082427040167, 082427040220, 082427040240, 082427230111, 082427230104, 082427050039, 082427110122, 082427110075, 082427110069, 082427110064, 082427110110, 082427110156, 082427110123, 082427110092, 082427110112, 082427110128, 082427110113, 082427100316, 082427100278, 082427100322, 082427080077, 082427080055, 082427160251, 082427160189, 082427160274, 082427180040, 082427270069, 082427120187, 082427120205, 082427120200, 082427120202, 082427120190, 082427200164, 082427200089, 082427070207, 082427070164, 082427070166, 082427070179, 082427140170, 082427210193, 082427210161, 082427210155, 082427210163, 082427210171, 082427190122, 082427150084, 082427220111, 082427310113, MR5907CO, CS1006MR05, EG1526MR05, M44849103, M4172341, MQ1000MR02, M4480267, M4035023, X41944010, M4213551, HC0220MR03, TP4447MR02, PC3003MR01, HC5284MR04, PC3827MR02, 265361MR01, HC3068MR01, HU1098MR02, HU1039MR05, 083027840038612, 083027848548411, 083027023407516, 083027287396017, 083027000049312, 083027000011318, 083027005023718, 083027000013713, 083027000042711, 083027244278914, 083027246282014, 083027100000000, 083027063155516, 083027860052014, 083027868823917, 083027861452415, 083027900000000, 083027284039818, 083027203474520, 083027202671920, 083027200000000, 083027200005613, 083027207288618, 083027200034313, 083027600000000, 083027046705715, 083027045753817, 083027806724415, 083027804408615, 083027603405819, 083027020204715, 083027024450217, 0835270026, IR1315MR01, IE1100MR02, IE1226MR01, A5547422, A5360437, A5111746, B5174327, A5719869, EM0293, EM0301, EM0255, EM0277, EM0214, EM0243, EM0230, EM0238, YM1399, EM0248, EM0282, EM0269, EM0273, EM0228, EM0213, EM0234, EM0235, EM0262, EM0215, EM0229, EM0232, EM0296, EM0281, EM0270, EM0280, EM0292, EM0275, EM0265, EM0207, EM0261, EM0257, EM0259, EM0209, EM0260, EM0250, EM0216, EM0264, EM0254, EM0244, EM0231, EM0291, EM0289, EM0276, EM0294, EM0221, EM0295, EM0290, EM0268, EM0286, EM0266, EM0201, EM0258, EM0278, EM0279, EM0211, EM0236, EM0204, test-123445, GE-APT-TEST5, EM0224, EM0237, EM0217, EM0242, EM0218, EM0247, EM0226, EM0321, EM0246, EM0212, EM0210, EM0249, EM0297, EM0288, EM0205, EM0222, EM0267, EM0225, EM0287, EM0239, EM0227, EM0208, EM0202, EM0284, EM0263, EM0283, EM0241, EM0240, EM0253, EM0271, EM0272, EM0223, EM0220, EM0233, EM0274, EM0206, KA1023MR02, 0850270426, 0850270427, 0850270411, 0850270459, 0850270521, 0850270598, 0850270481, 0850270478, 0850270446, 0850270430, 0850270455, 0850270436, 0850270409, 0850270414, KW1013MR04, KW1001MR06, KW1005MR05, KW1019MR03, LV4032MR01, LB1331MR01, LB1006MR02, MRUA0501, MR308183MR3, MRUA1296, 2806034DVR750, RTD0191, UDN0121, PK1122MR01, PL3116MR01, PL3554MR01, PL3277MR01, 600042MR02, 5379608MR11_TEMPUPGSID, 5370769MR41_TEMPUPGSID, 5370769MR31_TEMPUPGSID, 5370769MR11_TEMPUPGSID, MRUA1663, MR2062PR, RO1098MR02, RU1111MR02, RU3338MR02, RU1717MR01, RU8438MR01, RU8438MR03, RU5599MR01, RU8792MR01, RU9279MR01, RU8615MR01, RU8937MR01, SA1041MR03, SA1037MR03, SA1223MR01, SA1162MR01, SA1036MR04, SA1255MR03, SA1058MR03, SA1033MR01, 0847270026, 6073MR0003, ZA2812MR01, MPX30232, MPX94401, NPV60102, UE929526, DPN36500, 083027808002416, A042MR04, A202MR02, 259130MR12, 150250MR01, 725100MR02, 568987MR01, 0853270164, 0853270170, 0853270159, 0853270177, 0853270118IB1, 0853270141, 0853270180, 1573MR0012, 06162MRS01, 53008MRS01, 26001MRS01, 34348MRS01, AE1016MR01, AE1546MR01, 00440MRS08, 11706MRS01, 77266MRS03, 20312MRS01, 00010MRS02, 10678MRS01, 10692MRS01, 10722MRS01, 00230MRS01, 5973MR0007

Distribution pattern

Worldwide distribution.

device · product 8 of 26

SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance

Z-2466-2024
Recall number
Z-2466-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
123 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: UABMRPET, 480342PETMR1, 415493VMR4, 415723CHMR6, 415CBMRPWS, 415CBMRP, 415723SHMR15, 415723SHWS15, 415723SHMRW, 720482PETMR, DUPONTPETMR, 904953PMR3T, 404778PETMR, 617726PETMR, 301496PETMR, MAYOPETMR01, WCIDHKMR1, MSK68MR01, 914681MR3T, 503418PETMR, 503418PETMRSPIC, CHOPPETMR, 713792AMR19, 608262PETMR1, 414266PETMR1, DZ4291MR01, MR7949AR, MRUA0459, 210002MR01, 030130MR01, MRUA0479, 604822MRP1, 082427040215, 082427130107, 082427250097, 082427210164, 082427030119, 082427100282, 082427190178, 082427160323, 082427170035, 082427120212, 082427120313, 082427020118, 082427220136, 082427030216, 082427040292, 082427040280, 082427040207, 082427110082, 082427140224, 082427030160, 082427220094, 082427170048, 082427070262, 082427090310, 082427220114, 082427220112, 082427140163, 082427140138, 082427130192, 082427130193, 082427130194, 082427130195, 082427130180, 082427040222, 082427040235, 082427020108, 082427230116, 082427110117, 082427160373, 082427150088, 082427120373, 082427120381, 082427070319, 082427140168, 082427150134, 082427150124, 082427220079, 082427310151, CS1013MR01, DK1054PT24, DK1047MR07, EG2676MR01, FI1149MR02, FI1003MR03, MR51694181, A4493006, M40345211, M883443911, 083027609080621, IL1028MR07, A51299125, A51043290, EX0135, EX0133, EX0132, EX0134, EX0131, EX0130, KW1013MR09, KW1008MR03, MR52664941, RTD3120, RU8438MR04, MPX57802, ME5043181, NPD08400, O005MR02, AC001MR02, C001MR01, A210MR01, 120810MR03, 0853270166, 0853270188, 34452MRS01, 06002MRS05, 06008MRS03, 00133PMR01, 10311PMR01, 10732PMR01, 10728PMR01, 11080PMR01

Distribution pattern

Worldwide distribution.

device · product 9 of 26

Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System

Z-2467-2024
Recall number
Z-2467-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 714957MR, 209225VC450, 858939MR4, 858939MR3, 202476MR1, HSS75MR450, HSSMAGNETF, 713566SMITH3, 713566SMITH1, 832522MR2, 920830MR450, 304256MR2, 250727MR2, DK1083MR06, FI1052MR01, RMUE01MR04, A5624132, D5354206, SA1058MR02, SA1011MR03, CPZ43620, 00242MRS02, 05217MRS02,

Distribution pattern

Worldwide distribution.

device · product 10 of 26

Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2468-2024
Recall number
Z-2468-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
1607 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 907562450W, 907IAPMR1, 256ASURGMR1, 334826450W, 205991MR2, 205LMK450W, 205877450W, 205939450W, 205783450W, 205838MR4, 256840MR450W, 251621450W, 256973MR450, 334287MR, 251279MR1, 256571MR450W, 256737H450W, 205949MR450W, 256GMTMR450W, 256880MR1, 256HHMR2, 256881MR1, 256ODCMR1, 256HICMR2, 205702450W, 251435MR15T, 251450MR, 251476MR, 205333MR1, 334732HDMR, 334676450W, 251SARAMR, 334418450W, 256386MR450, 334636MR, STVT450W, 205750MR6, 205750MR5, 205450WSMR, 479754MR, 501585450W, 479571MR, 479709450W, 479452450W, 501346MR1, 501225450W3, 501225450W2, 501225450W1, 501221LEGACY450, 501202MR1, 870541JR450W1, 479964450W, 479757NW450, 870208MR450, 928214MR1, 480425MR9, 928453MW450W, 520666MR1, 480425MR11, 702616RDLMR, 480425MR8, 480882MR1, 623524MR1, 520TMCMR1, 520STMMR, 520ACPMR2, 520SMICMR, 6628, RADNETMR667, RADNETMR593, 916961450MR, 77266MR02, 619409MR1, RADNETMR630, 7462, 760452MR1, 6970K, 949557MR1, 530IIMR, 7951, 7688, 858824MR2, 661949MR450, 562826MR1, 562491MR2, ALLIANCEOPT02, 310289MR, ASLW450W, RADNETMR610, 209491SSMR, 951486MR, QUEEN450WMR, 818NHMR1, 510449MR450W, 530ORO450W, 6947, 8061, 951788MR, 916783450MR, 916SUTROSMR, UCDACCMR450, 916MCCMR, 415754QMR1, 8590, 619295HDMR2, 858549HDMR1, 415KSF450W, 415KMB450W, 408259MR450W, 510784MR450W, 510784MR450WSIL, 805898MR, 707576MR450W, 707521MR450W, 707546MR450W, 209SJMR, RADNETMR634, AVHTVGEMR, 805SCMR, 760830MR, 707651KVMR, 805CHMR1, 925210450WMR, 707459MR450W, 7493, 970544MR450W, 303341MR, 303444MR, 303498MR1, 303446MR, 719285DVMR, 303866MR, 719260MR, 970874MR, 303861MR1, 303427MRW, DOA450W, 720484MR, 970858MR, 303278MR, 303338MR2, 303338MR1, 303416MR, 720SAHMOBMR, 720708MR, 303673MR, 303269MR, 303577DVMR, 719560MR3, 970625MR450W, 970870450W, 303451MR, 303426MR, 303467MR, 203837MR450W, 860749MR, 860678450W, 203863MR450W, 203325MR450W, 860489MR450W, 203574MR450W, INSIGHTMR3244, 202476MR2, 302993MR, 561642MR3, 561642MR3RAD, 239VAMR2, 239VA450MR, 727462MR1, 954688MR1, 954346MR1, 863422MR1, 561495MR2, 904215MR11, 772LMCMR1, RADNETMR1692, 850862MR1, 305696MR450W, 352344MR3, 904308MR1, 904202MR10, 904202MR8, 904202MR7, 904223MR1, 561747MR2, 407OSCMR2, 407PMCMR, 386LCMR, 321WMC450W, 305835MR450W, 305854MR1, 850SHHDMR, NNHMR450W, 904639MR1, 407359MR, 850475450W, 850431450W, 813866MR, 813926MR1, 813972MR4, 813745MR5, 813745MR2, 00506MRS01, 561795MR2, 561845MR2, 863295MR, MSF072-1-26668WE8, 3011062, 706922MR, 770848MR, 770219BUMR, 3008010, 706494450W, 770918GEMR2, 770918GEMR, 912384MR1, 478272MR1, 706635450W, 706787450DV, 770533WMR, 706845MR, 478743450W, 770252MR, 912576MR, 3000158, 229228450W, 808HRAWMR, 808TAMCMR450W, 712243MR450, 515263MR450, 641754MR1, 712722MR, 319272MR, 319768MR, 515358MR1, 208678MR, WVMR450W, 208882MR450W, 847658OI450W, 630859MR1, 630264MRI, 847381MR, 630755AMR, 815705MR, 312563CMR, 773962SBMR, 773525MR3, 217876MR2, 847298MR, 217876FMR, 1000004458, 630208DMR2, 630384MRI, 618253MR, 217532DVMR, 847SAMCMR3, 815937MR, 1000004456, 847438MR, 217732LMR, 630946MR1, 630873MR, 1000004278, 217258SBMR1, 708681GMR, 630527MR4, 630527MR3, 815215MR, 815300MR1, 630724ROMR, 708684MR1, 630684MR450W, 708346MR5, 708346MR6, 708660ROPMR, 708361DVMR, 773792MRI, 309691P450W, 1000004986, 309691MR, 1000004469, 309672MR450W, 1000004048, 815399MR4, 1000004298, 815399MR2, 815971MR2, 815664MR450W, 815758MR, 815217MR1, 708429MRI, 630352MRI, 630716AMR, 847872ZMR1, 765646MR450, 260920MR, 812276HDXT, 812897MR1, 574546MR, 765365MR, 765362MR1, 574266MR, 260426VAMR, 765448MR450, 574335GMR, 765655MR, 317388MR, 317204MR1, 317338MR5, 317887MR2, 317865MR3, 765502MR1, 812265MR, 574335MR, 812858MWMR, 812842MR1, 812858OAMR, 812352HDXT, 260563450W, 574267450W, 574267MR, 765502MR2, 620442MR, 785239MR, 620275MR, 785623MR2, 620285MR450, 913682LVMRW, 913397DICOMRW, 913676SMBVMR, 913469JCMR, 913676SUNMR, 785452SMR2, 785TPVAMRW, 316268MR450, 316262MR450, 316858MR450, 620221WMR, 270527MMR, 859301MR, 502868MR3, 859442MR, 270251JPMR, 270441LMR, 270444LMR1, 859744MR450, 318769MR, 225ICL450W, 985ONCMR, 985NOMR3, 985873TMR4, 337593MR2, 504VAMR15, 985SAMR, 318798450W, 985447MR15, 985WCMR15, 337363MR450, ALLIANCEOPT01, MSF061-1-1Z7GPHJZ, MSF061-1-20JU-1055, MSF061-1-20JU-1056, MSF061-1-20JU-1057, MSF061-1-20JU-1058, MSF061-1-20JU-1059, MSF061-1-20JU-1264, MSF061-1-20JU-1265, MSF061-1-20JU-1266, MSF061-1-20JU-1268, MSF061-1-20JU-1476, MSF061-1-20JU-1477, MSF061-1-20JU-1479, MSF061-1-20JU-1480, MSF061-1-20JU-1690, MSF061-1-20JU-1692, MSF061-1-20JU-1693, MSF061-1-20JU-1694, MSF061-1-20JU-1901, MSF061-1-20JU-1902, MSF061-1-20JU-1903, MSF061-1-20JU-1904, MSF061-1-20JU-1905, MSF061-1-20JU-197, MSF061-1-20JU-200, MSF061-1-20JU-201, MSF061-1-20JU-2111, MSF061-1-20JU-2112, MSF061-1-20JU-2114, MSF061-1-20JU-2115, MSF061-1-20JU-2331, MSF061-1-20JU-2332, MSF061-1-20JU-3195, MSF061-1-20JU-3196, MSF061-1-20JU-3407, MSF061-1-20JU-3408, MSF061-1-20JU-3409, MSF061-1-20JU-3410, MSF061-1-20JU-3411, MSF061-1-20JU-415, MSF061-1-20JU-416, MSF061-1-20JU-417, MSF061-1-20JU-418, MSF061-1-20JU-419, MSF061-1-20JU-632, MSF061-1-20JU-633, MSF061-1-20JU-634, MSF061-1-20JU-635, MSF061-1-20JU-843, MSF061-1-20JU-844, MSF061-1-20JU-845, MSF061-1-20JU-846, MSF061-1-2336-80024, MSF061-1-2701Y0FK, MSF061-1-27MG1GBU, MSF061-1-2B6T-12893, MSF061-1-2B6T-173074, MSF061-1-2B6T-59585, MSF061-1-2B8TE81Q, MSF061-1-2JNX8OTC, MSF061-1-2KIQGX1X, MSF061-1-2L2WDE0S, MSF061-1-2M80VFWX, MSF061-1-2RT9JOE9, MSF061-1-2VA2GB6P, MSF061-1-2WU53JR5, 617499MR2, 978287MR, 508548MR, STLUKESOPTMR, ALLIANCEOPT05, MORTON450WMR, 413568MR, 781HV450MR, 410266MR3, RADNETMR1691, 240480MR, RADNETMR1614, 301295MR8, 301295MR6, 301295MR5, RADNETMR1588, 240566MR2, RADNETMR1721, RADNETMR1604, 240313MR, 301279MR3, RADNETMR1660, RADNETMR1594, 207973MR450W, 207338MR450W, 207OA450WMR, 313593MR450, 1000000576, 616774MR450W, 616391450W, 616267MR450, 517668MR, 517450W, ALLIANCEOPT06, 248898MR450, 989907MR, 586573MR450, 507373MR1, 952831MR3, 218828MR, 952456MR450, 320523MR1, 651267MR1, MR229053, MR229045, MR229043, MR229044, MR229042, MR229040, 651287MR1, 651968MR450W, WH231MR450, 816932BSMRW, 417348MR2, 417358MR2, 573815MR4, 636933JMR1, 573556MRW2, 417STJ4502, 417STJ450, 816861MR1, 816932MRW, 816561MRW, 314543SAMR1, 417533MR3, 816347GEMR, 417354MR1, 573686VA450W, 314251MMR2, 417269MCMR3, 417COXMR2, 636239DVMR, 636MOTIONMR, 601932MR450W, 601968MR450W1, 601354MR450W, 662932MRIROC, 662841MR5, 406293MR450W, 406543ART2, 336625DVMR, 828225MRW, 828213RMRW, BRUNSWICKMR, 828883MR450, 704323DVMR, 704384MR450, 828456MRW, 704403DVMR, 919470GEM1, 252482MR450, 910609MR2, 910609CFMR1, 910323VRIMR, 530225MR, 252847MR450W, 252436MPMR, 828696MRW, 910577GEM, 828759MR1, 910CHMR450W, 704CMCLMCMR, 704660DVMR, 910CFHOKEMR, 336503PMMR, 919JM450W, 910457MR, 828586MRW, HERITAGEMR, 910642MR, 910667MR, 910WHMR, 910NHO450W, 336765MR1, 336760DVMR, 701567MR450, SMSLMS4, 308398HDMR, 308995PMR, 402SEMR450W, 402873NEBMR, 402609ONMR, 308255MR, 609407MR, 201858MRW, 908277MR1, PENNCH450W, RADNETMR6069, 732450WMR, 973301MR2, 973301MR, 609242MR450W, 441MR450, 609584MR450W, 973322MRW, 973325MR, 201579MRW, 609267MR, 732776MR450W, 732938MR, 732249MR, 973926MR, 609380MR, HSSPRMSMR450W, 908859MR, 732892MR450W, RADNETMR1650, 973361MR, 732246WMR, 908685MR450W, 201836MRW, 732557MR450W, 908851MR, 856794MR, 856768MR, RADNETMR6061, 908232MR450W, 505262MR, 505863MR450, 505287MR, 575622MRW1, 702616MR450W, 702PKWYMR, 775SMMR450W, 518842MRI, 914273MRW, SINAIQ2MR450W, SINAIQMR450W, 631968MR, MKMG450W, 718270MR, RADNETMR1722, 518579MR, 631499MR450, 631623MR450, 631689MR450, 315MDRBRIT, ALLIANCEOPT03, 631723MR450, 845794MRW, 718738MR, 631923MR, INSIGHTMR3249, 845943MR, 315823MR, 631405MR450, ORMCMR1, RADNETMR1603, 212523MR3SS, MSPACC450W, RSVLTMR1450W, 212255MR, MSK53MR01, MSK68MR04, MR9ALLEN450W, RADNETMR1655, RADNETMR1674, HSSMAGNETI, HSSMAGNETH, 315922MR, 315SOSNORTH, 716712MR, 518563MRI, 518561MR, 845483MR, 516705MR450, 518897MR, 718818MR, 631638MR450, 845368MRW, 315SOS450W, 516HSSMR, WMED450W, RADNETMR649, 914288MRI, WMED450W2, 513732MR, 740439450W, 513584RIDMR, 513782MR, 513584MR2, 513624MR2, 513MWMR1, 614RMHTMR1, 440890450W, 419PRODEF, 614LCHCMR, 937278MR2, 513870MR1, 937WHMR, 614663MR, 614HMOBMR, 614MCHFMR, 440960MR450W, 419ARROWMR, 419STCHARLESMR, 419PERRYMR, 740886MRW, 419455MR, 419251MR, 419WYMR, 513298MR2, 513298MR3, 513298MR1, 440827MR450W, 330263450W, 740454MR, 918333JPMR2, 918333JPMR1, 580251MR2, 405359EMR, 918787MR, 405912MMR, 405307NMR2, 405486MR2, 405842ACMR, 405271PMR1, 405271PMR2, 405814MR, 405270VMR2, 405486MR, 580765PMR, 918523MR2, 918879MR, 918712MR1, 918744SJMR3, 918744SJMR1, 918893TCIMR, 918744SJMR2, 918599MR, 918307MR, 918523MR450, 541706MR, 541317MR, 541SAGHMR, 503216PRC, 971310MR1, 541947MR, 503723PWFMR1, 541276MR450W, 503732MR1, 503220MR1, 610674MR, 610740MR4, 717867MR, 724773MR450W, PENNMEDMR, 412851MR, 610317MR, 610954MRW, 610997MRW, 610831450W, 814260MR450W, 724772MR, JOI610450W, 484503MR, 724981MR450W, 814643MR450W, 215949MR, 717272MR, 717485MR1, 412942MR2, 814333MR450W, 717791MR1, 717975MR2, 412372MR1, 215JEANESMR, 215707450W, 215537MR, METHODISTMR450W, PHILLYNAVYMR, 215ARIA450W, JHN450W, 215829MR1, STCHRISMR, 412647PUHMR2, 412232MR450W, 724934MR, 412358MR2, 412623SDHYMR3, 814676MR450W, 814234MR450W, 484526MR, 215201MR, 724229MR1, MRH1154, 864225DVMR, 843762CCMR, 803791MRI, 803434DVMR, 803751MR, 843292MR450, 864255SFMR, 864675ESMR, 864725MRI, 843784450W, 843339450W, 803313DVMR, 803329DVMR, 864560DVMR, 605725MR, 605217MR450W, 605721MR450, 605322MR2, 605322MR, 605677MR450W, 423844MR1, 423553MR450, 931245MR2, 901GTMR450XP, 901755MR450, 901GTMR450, 424622OPT1, 731661MR1, 731541MROP2, 865471MR450, 865545450W, 865525MR2, 615TO2, 901REGIONONE450, 901VAMR450W, 901384MR450, 901726MR450, 615329VAN, 615327MR450, 615PRADMR1, 731644MR2, 931363MR450W, 931967MR450W, 325307HPMR, 325670HMR1, 325670ICMR, 817472TSMR1, 512UTMR, 512TSIMR1, 512816SAMR, 979CTSMMR1, 512CPMCMR2, 214828MPMR1, 972566WMR2, 972566WMR4, 214341PDDMR2, 214302PDWMR1, 817BSFWMR1, 817FPMCMR1, 817321RATCMR1, 972495TSGMR1, 512GTMRI, 956365MRW, 713792AMR20, 713792AMR15, 303466MR, RADNETMR685, 713798MR2, 713441MR6W, 713792AMR13, VINTAGE450, 972868TLCMR1, 972969LCMR, 817482BKMR1, 832995MR1, 281348450WMR, 210WHASCMR2, 512LRMCMR, 806775MR, 806775MR450, 903927MR450, 469820BMWMR1, 254562MR450W, 432221MR, 936569MR450W, 830500RHMR1, 817255NHMR, 432333MR, 903731MR450, 903737PRWMR1, 713PRLDMR1, 432447MR1, 956487MRW, 210617HUBMR2, 210MSMTMR, 210MSSPMR, 903870BSHWMR1, SPRINGWOODMR1, 281276MR450W, 903439HC450W, 281943MR450, 903877UT450W, 972923BWAXMR, 281338MR450, 469649EWMR1, 435868MR, 435716MR1, 801IMCMR02, 801IMCMR4, 801262MR3, 801387MR1, 801479MR2, 801373MR5, REVERESGMR2, 801321LMR1, 801535MR1, 801501MR2, 801475MR1, 801GR450WGEM, 703664MR, 540953MR450, 434MJMR1, 757312MR, 804CHI450W, 434799MR1, 571349MR1, 276236MR450, 540862MR, 276666MR450W, 804WAT450, 757886MR1, 757261MR, 757398MR450W, 757953450WMR, 703205MR2, 276596450W, 804CHIP450W, 804OV450W, 804330MR450W, 434447MR, 802371MR, 206244HM450, 425450PMR, 425222SMRW, 360507450WCM, 509546MR450W, 425111SMRW, 509946NWOMR, 509TCOMR450W, 206292SR450W, 509482450W, 509837MR450W, 253596GHTMR, 360571MR1, 509573MR450W, 715623MRW, 920885MR2, 262303MR1, 262785MR1, 608930MR1, 414325WB1, 262656MR1, 608775MR1, 608890MR450W, 608263MR4I, 715748MR1, 262243MR1, 414649WB3, 414805MR1, 262687MR1, 304367MR450W, INSIGHTMR3248, 307ELEVMR, 307587MR, 307SWRMR, DZ1006MR01, DZ1101MR01, DZ1714MR01, DZ1525MR01, MR3698AR, MR6815AR, MRHM0774, MRHMO893, MRHM1139, MRHM1148, MRHM0560, MR9459AR, MRHM1192, MRHM0930, MRHM0559, MRHM1405, MRHM1496, MRHM1176, AM1019MR01, 83109684989, 0910272085, 83174615975, 83155846259, 83115138353, 83096537610, 83120699996, 83096322871, 83121616194, 83107577438, BH1037MR01, BY4027MR02, BY4190MR01, BY4084MR01, BY4184MR01, BY4033MR02, BY4178MR01, BY4160MR02, BY4035MR01, BY4033MR01, 210036MR02, MRHM1424, MRHM1361, MRHM1346, MRHM1315, MRHM1244, MRHM1141, MRHM1310, MRHM0842, MRHM1536, MRHM0158, MRHM1460, MRHM1260, MRHM1268, MRHM0711, MRHM0649, MRHM0430, MRHM0145, MRHM1100, MRHM0712, MRHM1065, MRHM1406, MRHM1213, MRHM0788, MRHM1297, MRHM1278, MRHM0177, MRHM0208, MRHM1207, MR307144MR6, MRHM1317, MRHM1217, MRHM0350A, MRHM1837, MRHM0950, MRHM0342, MRHM0885, MRHM0448, MRHM0264, MRHM1033, MRHM1719, MRHM1601, MRHM1704, MRHM1577, MRHM1596, MRHM1572, MRHM1590, MRHM1566, MRHM1551, MRHM1544, MRHM1309, MRHM1119, MRHM1061, MRHM0937, MRHM0897, MRUA0184, MRHM0323, MRHM0523, MRHM0409, MRHM0358, MRHM0269, MRHM0267, MRHM0266, MRHM0228, 2879385, 2884624, BG4013MR01, BG4693MR01, 403777MR2, 403670MR1, 613938MR1, 450466MR1, 514934MR1, 514934MR2, 514890GEMR1, 514890GEMR2, E416249MR1, 604582MR450, 416212MR450, 902893MR1, 506544MR1, 506739MR1, 506862MR2, 905522MR2, 613721MR1, 416486MR4, 514262MR1, 450654MR450, 306569MR1, MR8485CL, MR4187CL, MRHM1067, HR4199MR01, CS1343MR01, CS1236MR01, DK1001MR02, DK1047MR05, DK1044MR02, DK1044MR03, DK1029MR04, DK1042MR02, DK1645MR01, MRHM1288, MRHM1323, EG1097MR03, EG1024MR02, EG1958MR01, EE4012MR01, FI1149MR01, FI1023MR02, FI1015MR05, FI1015MR04, M4166668, M4042028, M1754007, E4167655, GF1006MR01, M4172346, M4464821, MQ1000MR01, M4176535, M4486930, M5173635, M4516029, T4185506, M2795512, X41944006, X41944020, NC1028MR01, PF1000MR02, X616331701, M5400573, M40180132, M4040554, M41980122, G4197601, M4145035, X681864011, GF1001MR01, X4211004, M6015637, GE1158MR01, GE1216MR01, HAMB01MR01, PC4318MR02, UC1590MR04, 662455MR01, HC4218MR04, PC0303MR02, CC3398MR02, 387194MR01, 210219MR01, 805534MR01, HC9039MR01, 527556MR01, PKOB02MR06, HC2555MR01, 418262MR01, CC5340MR01, 118150MR01, HC6474MR01, 604529MR01, HC2259MR02, 220068MR01, CC6785MR01, 446281MR01, 355495MR02, PC0352MR02, HWIL01MR01, 125528MR03, CC7903MR01, 898660MR01, H10645MR23, H7009MR07, H43381MR02, MR6821GT, 0828270043IB01, 0828270037IB01, HU1906MR01, HU1113MR01, SYNMR001, HU1047MR01, 083027600046413, 083027606283420, 083027003811911, 083027822002316, 083027860027512, 083027605463214, 083027601000614, 083027605456914, 083027608914014, 0835270042, 5512MR0005, 0835270039, IR2273MR01, IR2047MR01, IR2243MR01, IR2088MR01, IR1814MR01, IR1925MR01, IR1519MR01, IR1310MR02, IQ1397MR01, IQ1638MR01, IQ1127MR01, IQ1578MR01, IE1079MR02, IE1053MR02, IE1226MR02, IL1059MR01, IL1041MR10, IL1194MR02, D174150001, D5343401, A5366629, A5383313, A5312220, A356832101, A5808532, A6012608, A5119449, A5813110, A126322010, A343134113, A5303339, A209695501, A232197306, A5228517, E5803915, F5367812, A6233904, A5381507, A56364172, A5274842, A457982901, B5105197, A5145927, A5272210, A5358122, A5295818, A5167933, A5196821, A5379317, A5214949, A51529155, B5354501, A202090803, A5359213, A409329103, A5634729, A5164526, A5354109, A5249511, E5141702, EM0152, EM0153, EM0117, EM0127, EM0106, EM0111, EM0124, EM0105, EM0150, EM0170, EM0113, EM0138, EM0135, EM0177, EM0119, EM0108, EM0110, EM0128, EM0121, EM0103, EM0122, EM0132, EM0125, EM0130, EM0141, EM0120, EM0101, EM0142, EM0123, EM0114, EM0151, EM0112, EM0129, EM0139, EM0133, EM0134, EM0155, EM0145, EM0137, EM0200, EM0136, EM0118, EM0109, EM0140, EM0116, EM0107, EM0115, EM0131, EM0104, EM0126, JO1053MR01, KA2856MR01, 0850270654, 0850270329, 0850270337, KW1102MR02, KW1100MR01, KW1067MR02, KW1067MR01, KW1011MR01, KW1011MR02, KW1005MR06, KW1005MR07, KW1005MR08, KW1098MR01, LB1331MR02, LB1027MR01, LB1250MR01, LB1348MR01, LY1086MR02, LT4003MR02, LT4089MR03, LT4041MR02, 1553MR0006, MRHM1736A, MRHM1986, MRHM2173, MR45W1800001, MRHM2181, MRHM1958, MRHM0967, MRHM0722, MR307145MR3, MRHM0562, MRHM1306, MRHM1053, MRHM2187, MRHM0828, MA1521MR02, MA1521MR01, MA1135MR02, RTD0424, RTD0422, TLB0229, UDN0120, 0920279032, NO1146MR02, OM1000MR02, OM1010MR01, PK1539MR01, PK1462MR01, PK1415MR01, PK1032MR01, PK1297MR01, PK1031MR01, PK1479MR01, MR8753PA, MRHM1427, MRHM1366, 1557MR0004, PL0739MR01, PL1735MR03, PL1735MR02, PL2902MR01, PL1499MR03, P00642MR01, PL2822MR02, PL1196MR01, PL1609MR04, P00007MR01, P00678MR01, PL1029MR01, PL3478MR01, P00495MR01, PL1426MR03, PL1059MR02, PL1501MR03, PL1502MR01, PL1190MR01, PL1491MR03, PL1684MR02, PL2773MR01, PL3362MR02, PL2762MR01, PL1544MR02, PPR07934, PPR83716, PPR00613, MRHM1126, MRHM1154, QA1125MR01, RO1104MR02, RO1426MR01, RO1096MR03, RO1188MR01, RF1737MR01, RF0444MR01, RF2839MR01, RU0004MR02, RU3293MR02, RU3637MR01, RU2076MR02, RU2551MR01, RU3007MR01, RU1158MR01, RU6340MR01, RU0472MR01, RU7346MR02, RU7346MR01, RU3362MR01, RU2580MR02, RU3894MR01, RU2527MR01, RU1127MR03, 600098MR01, RU2272MR02, RU2442MR01, RU1089MR07, RU1089MR06, RU1106MR02, RU9000MR01, RU7285MR01, RU1086MR05, RU1516MR01, RU8541MR01, RU1092MR02, RU1089MR05, RU8438MR02, RU7620MR01, RU9515MR01, RU7762MR01, RF0209MR01, RU3970MR01, RU0063MR01, RU1050MR02, RU9940MR01, RU2526MR02, RU1143MR02, RU3464MR01, RF1204MR01, RU0740MR01, RU3431MR01, RF0309MR01, RU1153MR01, RU2804MR01, SA1014MR03, SA2135MR02, SA1060MR01, SA2591MR01, SA1051MR02, SA1080MR01, SA1037MR02, SA1188MR04, SA1188MR03, SA2385MR01, SA1035MR01, SA2315MR01, SA1004MR03, SA1036MR03, SA1253MR01, SA1052MR03, SA2339MR01, SA2079MR01, SA1272MR01, SA1208MR01, SA1306MR01, SA1255MR02, SA2460MR01, SA2513MR01, SA2454MR01, SA5000MR01, SA5000MR02, SA5003MR01, SA1031MR02, SA1034MR03, SA1001MR04, SA1054MR03, SA1054MR04, SA1026MR01, SA1058MR04, SA1011MR04, SA2000MR01, SA1257MR01, SA1279MR03, SA1279MR01, SA1175MR01, SA1332MR01, RS4014MR01, RS4199MR01, 0847270027, 6073MR0015, 6073MR0010, 6073MR0007, 0847270031, SI4120MR02, SI4120MR01, ZA2195MR01, ZA3164MR01, DPN85203, NP739728, MP720808, UPW07915, DPN89112, DPM88007, DPN36504, MEX68909, DPN88623, NEV13613, FPD10804, DPD26400, FPD30600, F009MR01, E001MR03, Z001MR03, A042MR03, A203MR04, A203MR05, A020MR04, A106MR01, A101MR01, S003MR01, 350010MR04, 899010MR03, 959204MR01, 124826MR01, 122002MR01, 541010MR05, 0853270162, 0853270208, 0853270171, 0853270128, 0853270172, 0853270120IB1, 0853270178, 0853270154, 0853270144, 0853270140, 0853270127, 0853270165, 0853270153, 0853270147, 0853270135, 0853270175, 0853270148, 0853270130, 0853270169, 0853270160, 0853270196, 0853270183, 0853270137, 0853270185, 0853270173, 0856270072, 0856270062, 0856270063, 1573MR0013, TN1624MR01, TN1678MR01, TN1674MR01, 19002MRS03, 06049MRS01, 34405MRS01, 34388MRS01, 34389MRS01, 34386MRS01, 34387MRS01, 34368MRS01, 34006MRS04, 34524MRS01, 06002MRS04, UA4369MR01, UK1142MR01, AE1212MR01, AE1007MR02, AE1742MR01, AE1558MR01, AE1477MR01, AE1036MR01, AE1015MR01, AE1027MR01, AE1042MR01, AE1235MR01, AE1122MR01, AE1200MR01, AE1476MR01, 00538MRS01, 10580MRS01, IE1566MR01, 05169MRS02, 00373MRS01, 05228MRS01, IE1564MR02, IE1267MR01, 10683MRS01, 70001MRS13, 70001MRS10, 00440MRS04, 10671MRS01, 00246MRS01, 01507MRS01, 01110MRS01, 00393MRS02, 10443MRS01, 00556MRS02, 00556MRS03, 00680MRS01, 00132MSS02, 01215MRS01, 77526MRS01, 10307MRS04, 01305MRS01, 10462MRS02, 00213MRS02, 00568MRS03, 00259MRS01, 21274MRS01, 00669MRS02, 01314MRS01, 20483MRS01, 00768MRS01, 00223MRS03, 10537MRS01, 11073MRS02, 00084MRS02, 10429MRS01, 10036MRS01, 7911, 864282MRW, 2948529MR, UZ1049MR01, UZ1041MR01, UZ1010MR01, UZ1043MR01, UZ1031MR01, UZ1021MR01, MRHM1085, MRHM0454, ESMRI26851837.

Distribution pattern

Worldwide distribution.

device · product 11 of 26

SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2469-2024
Recall number
Z-2469-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
1228 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 907ULMC3T, 907264MR, 907729ANMR, 907580MR, 907796JMR, 907443MR, 205SBMR, 256ALIPM450, 256ALOPMR, 205934CVMR, 205BVAMR2, 205BVAMR1, 205592MR4, 205783MR3, 256768MR450, 205608MR, 256265STMR, 256SRIPM450, 256CCIMR1, 256HHMR3, 256MHMR1, 334286BSMR, 256386AV450, 334358MR2, 501661VA450, 928639MR1, 602588MR2, 623882MR, 520OVHMR, 602655MR1, 602406MR5, 602532MR, 623683MR1, 602277VAMR1, 602923MR, 928445MR1, 480324MR, 520USCMR1, 520UMIMR, 530332MR, 760370MR2, 559225VAMR450, 818790MR1, 562531MR, AVHLMMR, 805737MR2, 760631DVMR1, K10276, 415723CHMR4, 530MHMR, 650847KMR2, 650847KMR1, 951788MR2, UCDROCKMR, 916783450MR2, 916784MR3, 916KCIRBYMR, 916RASSMR, 916KJMR, GON5381894, 10835, 619543MR3, 858453VMR3, 415CPCHMR3, GON5429076, GON5429078, 415ARTKSRFMR, AVHTRMR1, 530SNMR2, 303695MR2, 303839MR1, 303837MR1, 3038998MR, 303788MR, 719524DVMR, 970945450W2, 970CPKMR450W, 970945450W, 970244AMPMR, 970RMOMR, 303SKYMR3, 303651MR, 303964MR, 719333MR2, 203739MR450W, 860545MRART2, 860545MRART1, 203276ART, 860231MR, 302744MR, 302430MR, 941798MR2, 813685MR, 954916MR2, 904321MR2, 376VAMR1, 904202MR18, 904202MR6, 904202MR17, 904202MR16, 904627MR2, 561844MR2, 321VHARTIST, 321HRARTIST, 321HF450W, 305223MR3, 305642MR1, 305665MR450W, LKNONAMR1, FHEARTIST2, FHEARTIST1, 386PCMR, 321PBARTIST, 4817325MR11, 850747DVMR, 813844MR2, 813844MR, 813745MR6, LMCPMR, 727834MR, HSSWPBMR450W, 561697MR1, HWARTIST, 229312MMRI, 706ARTISTMR, 404778MR1, 404778MR2, 404605MR, 706733MR, 706651AMR, 706651MR, 912466MR1, 706571MR, 3016508, 912435MR, 706692PJMR2, 678474JCMR2, 404605PKMR1, 770914MR, 912350CHOSMR, 912350GEMR, 229228ARTIST, 3012383, 808HMCMR, 808KMAPMR, AVHCSMR, 515643MR1, 319268MR, 563387MR, 515643MR450, 563584MR, 712264MR2, 712213MR, 319768GRMR1, 563422MR, 208422MR1, 208524MR, 208529MR1, 208557MRI, 208743ART, 208463SZMR, 208265BGMR, SLMVMR450, 847618MR2, 1000001238, 312947MR, 312702MR450, 217342BMR1, 847437AMR1, 1000003614, SMSOMR3, 618997VAMR1, 618288DVMR, 618288OWMR, 217258SBMR2, 708LOYMR2, 1000004956, 630326MR, 630953MR, 708349MR, 1000000047, 1000004953, 217BHC450W, 217528MR2, 630933MR, 630933MR3, 260665MR, 317582MR2, 812376MR1, 260432MR, 260425MRI, 765453MR, 219326MR450W, 574753ARTIST, 219877MR, 812842MR3, 812385MR1, 574223MR450W, 812522MR2, 574284MR, 785623HMRA, 913MMCMR, 913469CPMR, 913541OMR, 913676SMRW, 316858MRA, 316962WMRA1, 316962MR450, 606833MRW, 502350MR, 270798MR1, 606678ARTMR, 318448MR, 225OHGMRI, 318681CBMR, 985LVMR1, 504OKMR, 985785MR, 504TOURMR, 504CHMR15, 318681ARTIST, 985NSMRI, 225658LMR, ANGELLMR1, 617726MR1EL2, 617726ERMR, 978882MR1, 781340MR3, 413584MRART, 508693MVMR, 5427030MR41_TEMPUPGSID, 781SSHMR1, 781340MR2, 413794MRART, 781729MR, UMASSWORCMR2, 508363MR, 443843MR1, 240555AMR, 240964ARTIST, 240683MR, 410787MR1, RADNETMR1548, RADNETMR1703, RADNETMR1705, 301618MR2, 207MIDCOASTMR, 207778ARTIST, 207INTERMEDDVMR, 734845VA450MR, 313745ART2, 313745ART1, 810762MR, 810606ART, 517HILLMR, 517788ART, 269341ART, 906225ART1, 906225ART2, 989583ARTIST, 248849ART, 218333MR1, 763CDIARTMR, 218249ART15, 507238MR1, 320693MR, MR1114440, MR1046092, MR1114463, MR1045974, MR1004372, MR229063, 320251ART, 636256MCV450W, 816BRMCMR, 573815MR3, 573884MR15, 816CP450W, 816861AMR, 816276MRW, 636379MERCYMR, 314MERCYOPMR2, 314525MCCMR, 314251MMR5, 601668SIGNA, 228575MR, 601288DVMR2, 601268WDVMR, 601288DVMR, 228818DVMR, 662932ART, 228BIENDVMR, 406375HMR, 406751KART, 406327AMR, 406543ART, 704984DVMR, 828213MRW, 704863ART, 704667MR450, 704446DVMR, 704384BALL, 704304DVMR, 910470ART1, 919684DMPMR1, 919684CC450W1, 910907WAMR3, 828349AMCMR, 336832MR1, 252VMCART, 828659MRW, 980993ART, 336719MR, 919954RMR2, 252NDMR450W, 704487ART, 252VBART, WMCGEMR, 701857MR, 402228MR, 402926NHI, 402362DVMR, 603334ART, 603332ART, 603952MR1, BRMR2, 908828MR, 732836MRART, 732222MRART, 973971MR4, MSF169-1-6XRM9S2F, 973971MR450W, 973971MR2, 732745MR, 973579MR, 732747VETMR, 201447MRW, 856582MR, 856247MR2, 505998ARTMR, 505888MR, 505609MR, 575521MR1, SHIMR02616, 775SIERRAMR, 702880MR450W, 702731MR3, SUNRMR1, 702962MR2, 518262ARTIST1, 518262ARTIST2, 585343MR1, 631665MR450, 585758MR, 718963MR2, HSSBKMR450W, 716845MR2, 716862MR1, 518371MR, 315UBJART, MAINARTMR, 315LCGHMR, SINAI9MR450W, MSK68CIGIMR01, HSSMRIB, SINAI8MR450W, 212744MR1, 212939MR1, 212562MR2, MSKDHKMR1, HSSWSMR450W, HSSMAGNETA, COR586479, RADNETMR1689, MSK65MR3, 845348MR, 516763ART, 845454MR, 631548MR, 585785MR2, 585214MRAO, 585275MR3, 585275MR1, 585723UNITYMR, 585HIGHLANDMR, 585266MR2, 518382MRI, 518243MR, 516798MR, 718226MR2, 914631MR15T, 914681MR15T, HSSWPMR450W, 330489MR450W, 330363450W, 330363MR, 513584MR1, 513556VVMR, 513MWMR2, 614722MR1, 614293MR8, 937208MR2, 937641MR, 330342MR, 419LIMAMEMMR2, 419893MR, 740393MR2, MHSPRGEMR2, 419383ARTMR, 419407MR1, 330746MR, 740455MR, 580272MR2, 580272MR, 580223AMR, 580251MR1, 580548BWB, 405329NMR, 405755MR1, 405636SMR1, 405751MR3, 918458MR3, 918458MR1, 918458MR2, 918567MR2, 918367MR, 918502MR6, 918502MR4, 918502MR5, MSF169-1-6XXYDCOS, 918502MR3, 918286MR, 918256MR, 580774WMR, 503253MR1, 503813MR1, 503513PMMR1, 503537PNMR2, 503216SVMR1, 503215PPMR1, 503215PPMR2, 503216SVMR2, 503717SSMR1, 610740MRER, 814889MRART, 570645MR1, 724772MRART, FITZMR, 484822MR, 610333MR, 717334MR1, 717632MR1, 724357MRART, 814262MR15T, 484464MR, 412622MRART, 272639MR, JCIVOYAGER, 215955MR3G, 215FCCC450W, JEFFNAVY, JEFFCOB450W1, 412835MR1, 267985MR, 610628MR, 814237MR450W, 215674OP450W, 412650MRART, 570321MR, 610988MR2, 717812MR, 864512MR1, 843402ART, 843724ART, 843847MR, 803461MRI, 803313ART, 864487UPMR, 864227MR2, 864560PMR, 803313DVMR1, 843390MR, 843606MPMR, 843416ARTIST, 843692GSART, 843832SMR, 843549ART, GON5151028, 605256MR450W, 605995MR, 605341MR1, 605322MR3, 615446ART1, 615771MRMD, 901GTOPMR1, 615338ART1, 615SMTOPMR1, 615SUMMITMR2, 615SUMMITMR, 423794MR, 865305MR, 901523ART, 901227ART, 901516ART3215, 901516ART15, 423926MR1, 423926MR2, 615769MR2W, 615SCMR2W, 512BSWSAMR, 956350MRW, 325646MR, 512BSWBUDAMR, 817517MR1, 713790MR2, 832912MR1, 281758MR355, 972566MR1, 972566MCHSMR, 214276MR1, 830VVARTMR, 940536EDMR1, 214420CDIDMR, 806935MRI450W, 915832HOPE, 915577ARTIST, 817AMERMR1, 817922ADIMR1, 972497BSFMR2, 830426MCMR, 713527MR1, 713ACB4MR24, 713442KSMR6, 713442MR1, MHMOBILEMR1, 713442KSMR5, 281333MR3, 281588MR, 713442KSMR4, 713792AMR21, 713441MR10W, 281NWARTIST, 713791VAMR1W, 512SHMRI, 806UMCWM15T, 956632ARTIST, 972540MMWMR1, 469815BCMR1, 936568HDX, 972596MCPMR2, 972596MCPMR1, 972617REDMR1, 512341MR3, 210VHSART, 936275SAMR1, 713897MWMR1, 817424ESLMR1, 713442KSMR8, 713442FTBNDMR1, 972798ESWMR1, 936271MR2, 281401MR1, 903533HDXT, 361572CICMR, 254751PMR1, 817599WRMR1, 713442CLMR1, 801756MR2, 801299MR2, 435BCMR, 801LONEMR1, 435HEBERMR1, 435635MR1, 801LAYMR2, 801LAYMR1, 435623MR2, 801MCDMR1, 801714MR1, 435PARKARTISTMR2, 801465MR2, 801373MR4, 435893MR1, 801RIVMR3, 435251MR2, 801LEHIMR1, 801588MROR, 801268MRARTIST, 801588MR01, 801SSMR, 801SPFRKMR1, 276258MRART, 703204MR1, 804CHEDMR, 434799ART, 703573ART5, 703391MR1, 703805MR2, 5101520MR81, 540SRMCMR, 703573ART8, 703858MR1, 703205MR3, 804764MR450W, 804SF450W, 703689MR, 804225MR, 804JWSPMR, 804281450W, 540776MR, 757673MRART, 802775MR, 425637VM450MR, 509765MR, 509332MR450W, 425486EVMR, 206744HMR, 360744HM450MR, 509474SH15T, 509434ART, 509473ART, 509482MR2, 715838MR1, 920288MR2, 920406HDX, 608262MR2, 608ONCMR1, 608VAARTIST, 608262MR3, 608287MR1, 715735MR1, 414805MR7, 920729ARTIST, MR1020321, 920208MR1, 715346MR1, 608372MR, SHIMR02613, SHIMR02611, SHIMR02651, 920262MR2, 414778MR1, 262429MR1, 304255VMR2, 304766MR4, 304526SMR2, DZ4953MR01, MR6033AR, MR3158AR, MR8772AR, 0910272091, 0910272093, 83195528655, 0910274042, 83202332947, 833MR000019, 83185224328, 83211314049, 833MR000035, 833MR000032, AH7084MR01, 130083MR06, 190194MR01, 190052MR01, 080026MR04, 030020MR03, 030151MR02, 080038MR01, 019022MR01, 019022MR07, 080100MR01, MRPM0227, MRPM0122, MRHM2195, BA4017MR01, MRHM2198, MRHM2005, MRHM1985, MRPM0952, MRPM0126, MRHM1900, MRR7938, MRPM0178, MRHM2122, MRPM1089, MRR10280, MRHM2039, MRHM1996, BG4042MR01, 902465MR, 905522MR1, 613632MR1, KWMRIHDXT, 604534MRART, 403382MR1, 604463MRART, 506623MR1, 506857MR2, 514934MR3, E416249MR3, 514697MR1, 905684MR1, 506648MR3, 902567MR, 250370ARTIST, 514939MR2, 514939MR1, 416756MR2, 902470MR, MRHM2116, MR2651956V2, MR6447CL, MRHM2245, MRHM2207, MRHM2249, 37448269MR, MR6746CO, DK1001MR01, DK1044MR04, DK1044MR06, DK1044MR07, DK1044MR08, DK1029MR05, DK1030MR05, DK1030MR04, DK1567MR01, DK1296MR01, MR6826DO, EG1194MR01, EG2650MR01, EG2646MR01, EE4019MR04, EE4019MR03, FI1075MR01, FI1120MR01, FI1693MR01, FI1175MR01, FI1052MR02, X121122501, M2002652, 06825989, S41600139, S4160096, M4161669, X616953011, M4409451, M4164350, M373312701, A2032125, X1478403, M4018553, M4016052, A4167357, X4479206, M4167842, M220648614, M2740512, 08607638, 07290913, F4171514, M4016577, M4020545, 05803166, 05840914, M2148263, M4490023, 05841009, X59655535, A62925713, X2007313, X629257022, M4173507, 07616398, M4174556, 06283325, M23084341, M178899204, A178899201, X1617001, X106415412, 06442791, M1425524, M4216461, 05803153, M4548544, X756087027, M4183857, X90281622, X967501009, M1656640, M24313807, H68439574, X401876904, C21952109, M4144365, 07335100, M4459621, X2181508, 07893363, M4631109, M4499039, 06889963, M5480794, A4194463, M4134656, M40330128, M4037076, M2637327, M1400959, 07809641, A9190175, M9708014, M206565705, 07307575, M54849101, 06442787, M40345203, M176430616, M5484987, M22635307, A9190184, A9502027, M54606128, M2634911, M2634913, M215517204, A1588529, M4200637, X354818502, 9913017, M178710409, M41439106, M4484752, M2322266, M1460212, M401886301, X118196008, H4858987, M4210251, M4210253, M4475682, X4211056, M2848452, 6278434, M42155110, M42155108, M42155103, X220730403, M226407304, M45052120, 9063097, 7838453, 129619MR01, HC6051MR01, 125995MR01, 351482MR01, PC7479MR10, PC8740MR02, HJJH01MR01, PC1455MR02, PC0396MR11, 123702MR01, HC7498MR03, HC3702MR01, HC1770MR03, HPAD01MR01, HC3996MR03, UC1559MR03, PC3312MR02, GON5402630, H10392MR52, H1943MR12, 0828270052IB01, 0828270065, 0828270056IB01, 0828270063, 0828270053IB01, HU1677MR01, 083027001002910, 083027004207919, 083027002227411, R83027204626924, R83027244108223, 083027060255422, 083027009119914, 083027824772621, 083027821317819, 083027202100488, 083027201013310, 083027205726822, 083027208006511, 083027206937710, 083027064149415, 083027043313421, 083027808143521, 083027847234115, 083027847898022, 083027021913318, 083027021866615, 083027000042713, IR2452MR01, MR50351941, IE1265MR01, A5127236, A5992703, A5649021, A5130628, A5165733, A5624157, A5315597, A670060237, 09509308, A258001703, A127292419, C5323541, A51529243, D5249954, A5105766, A5314615, A5401395, EM0808, EM0924, EM0930, MR00078, GON5441641, EM0921, MR00087, EM0802, EM0805, EM0814, EM0918, EM0901, MR00245, EM0917, EM0809, MR00008, EM0811, EM0803, EM0812, EM0905, EM0801, MR00088, MR00208, MR00086, EM0902, EM0807, EM0815, MR00221, MR00012, EM0800, EM0907, MR00166, MR00158, MR00217, EM0925, MR00001, MR00056, MR00005, EM0804, EM0810, EM0900, MR00237, MR00238, MR00156, EM0915, EM0926, MR00230, EM0813, MR00248, MR00037, EM0806, MR00242, EM0911, 0850270460, 0850270538, 0850270432, 0850270323, 0850270317, 0850270227, 0850270636, 0850270395, 0850270307, 0850270399, 0850270298, 0850270449, 0850270157, 0850270224, 0850270664, 0850270714, 0850270428, 0850270513, 0850270127, 0850270173, 0850270278, 0850270424, 0850270065, 0850270389, 0850270314, 0850270252, 0850270133, 0850270789, KW1013MR06, KW1013MR07, KW1013MR08, KW1013MR05, KW1001MR04, KW1008MR05, KW1008MR06, KW1008MR07, KW1002MR01, KW1007MR05, KW1007MR04, KW1006MR04, MR52660981, MR52660991, MR52661284, MR51319271, MR51319281, KW1003MR01, KW1112MR01, KW1004MR04, KW1155MR02, 080017MR02, 080017MR01, 110807MR03, 110807MR02, 030013MR05, 0834270016, MRR9771, 2884783MR, MRR11569, MRHM2073, MR52993021, MR52992811, MA1877MR01, RTD01203, RTD01202, 85114777250, 859MR000011, 85155343850, 85177987565, 859MR000025, NO1011MR02, OM1007MR02, PK1035MR01, MR8375PE, MR2323PE, MR4604787PE, 1557MR0034, PL1476MR02, PL1584MR02, PL0551MR02, PL1580MR02, PL1689MR01, PL1661MR01, PL1698MR01, PL1312MR03, PL1312MR02, 600034MR01, PL2201MR01, PL3376MR01, PL1150MR02, PL1234MR01, 600042MR03, PL1169MR02, PL3254MR01, PER08329, PPR29816, MR1730PR, MR7598PR, MR53527301, RO1079MR01, RU9571MR01, RU1156MR01, RU1095MR04, RU7984MR01, RU1128MR02, RU1128MR01, RU3509MR01, RU1296MR02, RU2275MR01, RF2817MR01, RF1383MR01, RF0929MR02, RF3309MR01, SA2706MR01, SA2633MR01, SA1039MR03, SA2308MR01, SA1209MR01, SA1012MR06, SA1034MR04, SA2643MR01, MR51994661, RS4060MR01, RS4199MR02, RS4199MR03, RS4095MR02, 6073MR0042, 6073MR0049, 6073MR0045, 6073MR0041, ZA1374MR01, DEN272171, DEN272172, NPD29701, FPG103200, MPX82200, CPZ38301, NE203172, CE270998, FEC800342, FE421194, FED03936, UE929541, DE492A102, DED647172, DE5284115, DPN89122, DE5284116, DPD15902, DED647131, DPB15881, DPN26335, DEK78891, CEG94657, MEX617112, CPZ09633, CE165375, UPW25212, FE457A208, NEV439244, NP473633, NPV22537, NP473629, CPI21217, A004MR04, A004MR06, O009MR04, M007MR01, N004MR01, M001MR01, N002MR04, 788000MR01, 492360MR01, 121351MR01, 123953MR02, 850020MR03, 0853270191, 0853270231, 0853270194, 0853270207, 0853270213, 0853270228, 0853270197, 0853270215, 0853270198, 0853270217, 0853270232, 0853270209, 0853270199, 0853270225, 0853270204, 0853270205, 1573MR0043, 0856270046, 1573MR0009, 1573MR0027, 1573MR0033, TN1059MR02, TN1166MR01, 01085MRS01, 34727MRS01, AE1485MR01, AE1367MR01, AE1626MR01, 00487MRS03, 70001MRS12, 77624MRS05, 77624MRS07, 00222MRS02, 00243MRS09, 00243MRS06, 10572MRS02, 77055MRS04, 00109MRS01, 00440MRS09, 00740MRS03, 10223MRS01, 00507MRS02, 00130MRS04, 10044MRS03, 00203MRS02, 00203MRS01, 10627MRS01, 00025MRS02, 00025MRS01, 10307MRS05, 70383MRS06, 70043MRS06, 11187MRS02, 00023MRS02, 01050MRS01, 70065MRS05, 00230MRS02, 00131MRS02, 00263MRS05, 00020MRS07, 00020MRS03, 00223MRS04, 05249MRS01, 00240MRS02, 10433MRS01, 00244MRS02, 00674MRS02, 907ULMCARTIST, MRPM1147, MRPM0735, MR4362UY, 5973MR0009, 303467MR1, 570501MR1, 11923362, 0828270037IB02, 407303MRER (w/ EVO upgrade), 214420MR1 (w/ EVO upgrade), FPG46909 (w/ EVO upgrade), 215322MR2 (w/ EVO upgrade), 574296MR (w/ EVO upgrade).

Distribution pattern

Worldwide distribution.

device · product 12 of 26

SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2470-2024
Recall number
Z-2470-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
1528 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 907373VMR, 256SPMR2, 870642MR, 5340995MR11, KRMCMR2, SMSCIA2, 714229MR2, SHIMR02637, 310358VMR, RADNETMR664, 559447MRVOYA3, 559447MRVOYA2, 559447MRVOYA1, INSIGHTMR1397, 626359VMR4, INSIGHTMR1371, ALLIANCEVOYA04, 707431MR, 323294VMR, 310823VMR, SHIMR02636, 818496HCMR1, 209SUTBMR, SHIMR02625, SHIMR02617, 530OROMMR, SHIMR02645, INSIGHTMR1385, INSIGHTMR1378, SHIMR02647, 13412, SHIMR02648, SHIMR02635, SHIMR02654, RADNETMR648, SHIMR02639, ALLIANCEVOYA11, INSIGHTMR1376, SHIMR02650, SHIMR02638, SHIMR02624, 818708MR2, 707462VOYMR, 661HMVMR1, 760247VMR, SHIMR02653, 303750MR, 307630MR2, 719394MR, 970242VAMR, 3036140MR, 720513MR, 970879VMR, 860289VOYAGER, 860659MRVOYAGER, 203453VOYAGER, 860347VOYAGER, 203834VOYAGER, 302655MR1, 561996MR1, 813315MR, 352597MR1, ALLIANCEVOYA01, 305445MR1, 904CSMR, 904627MR3, SHIMR02652, 321CLMRVOY, 305229MR1, 239NHVOY, 352ADVMR, 352867MR2, 941MPGPGVOY, 813655MR, 813874MR1, 941VOYMR, 850325MR1, 850877MR1, 229758MRI, 770539MR, MSF138-1-6XIAHPU7, 478745VMR, 229329MRI, SMSVIT7, SMSSVM8, SMSZOE3, SMSKIT1, SMSSVM1, SMSMAG1, SMSCAM2, SMSAMP1, SMSOMR1, 712737MRVOY, SMSWES4, 319352MR, SMSOAK2, 208735VOYMR, SMSCIA1, SHIMR2667, 618GOSHENMR, 847931MR, DSSMR5, SMSCAM1, 1000003628, 217QMGVOYAGER, SMSOMR5, 847252MRI, SMGMR59, DMSMR166, SMSZAG1, 812348MR2, 317415VOY, 574537MR, 574647VOYAGER, 574271MR, 812663MR2, 317899MR, 812283MR, SMSOMR2, SMSSVM4, SMSSVM3, 316613MR, 606833MRW2, DSSMR6, 606598MR2, 985ONCMR2, 4600722-MSF116-1-1-1, 985FWMR, SMGMR44, 337593VOYAGER1, 337470MR1, 318251GCVOYAGER, 978922MR, NBHMOBILEMR2, 617789MR, 508548MR1, 508825MR1, 781952MR, RADNETMR1712, RADNETMR1701, 301618MR1, 269979VOY, 248VOY, SJMOBILE, ALLIANCEVOYA10, 586263VOYA1, 248553VOYAGER, 810732VOYAGER, 906483VOYA, ALLIANCEVOYA03, ALLIANCEVOYA02, 269342VOY, 517VOY2, RMIMOBILEMR, ALLIANCEVOYA06, ALLIANCEVOYA08, 989583VOYMOB, ALLIANCEVOYA09, 952738MR1, SMSVIT1, 507537MRVOY, 612RICMR, 507825MRVOY, 320255VOY, 651747VOY1, WC231MR, SMSVIA1, SMSSVM2, 417891MR1, 601936VMR, 662377VOYMR1, 601883VMR, 406237TMR, 406587BOMR, 406455MR2, 406445CMR, 406449BMR1, 406751MMR, BPMOBILEMR12, BPMOBILEMR11, 828250VOYAGERMR, 828213MHMR, 4975485MR11, 704820VOYA, 704323MOB1, 704831CNMR2, MQ29NORFOLK, 704697VOYA, TRANSTATEMR1, 704783VOY, 980212MR, 704834VOY, 828681AHMR, 704895VOY, 980993VOYA, 252OBHMR, ALLIANCEVOYA05, 828766BRMR, 704CISMOB3, 910CRVOY, 701444MR, SMSWAY1, SMSSVM5, SMSOAK3, SMSKIT2, 402336VMR, MOB14GEMR, RADNETMR1693, SHIMR02618, ATLHLTHCLK, 732497MRVOY, 609597MRVOY, 973370MR, 732988MRVOY, 201261MR, 973837MR, LARCHVOYAGER, PMIM122MR, 775827NRHPMR, 518262VOYAGER, 518438MR2, 716250MR, ALLIANCEVOYA07, 718613MR, 718963MR, 716204VMR1, 716250VMR1, 585NOYESMR, 516GCVOY, 607535MR, 716217MR, 607337MR, 631758MR, 607865MR, 585716JONESMR, 631998MR, 914962MRI, 330AULTMR1, 330AULTMR1B, 330MMCM1, 724029MR1, 330AULTMR1A, 513793MR, 937236MR, 330AULTMR1D, MHKMMR1, 513424KHMR, 724029MR2, 740991MRW, WCOHC3, MHSPRGEMR1, 419933MR, 405224GMR, 580354MVMR, 405230MR, SMGMR46, 405749OSMR, SMSSVM6, 405273PMR, 405743MR, 918523MR3, 918940MR1, 405350MR, 541383MR, 541472VMR, 610402MR, 610317MR1, 717761MR3, 814624MR, 484498MR, 484224MR, 835215MR, SHIMR02646, 215707VOYAGER, 570621MR, SMGMR56, 570307MR1, 717765MR, 401793MR, 803936LMCMR4, 864229MRI, 843716MRV, 843236CFVOY, 803992VOY, 803936LMCMR1, 605217MRVOY, 605598MRVOY, SMSOAK1, 423697MR2, 423697MR1, 615WBJMR1, 615986HVPR, 865584MR2, 901516VOY, 806212VMR30, 817358HCABMR1, 713314MHOPM, 817293HMR1, 469221ADHMR1, 817294TSWMR1, 713451VOY1, 281955MR1, 713778MR1, 832658MHMR1, 817498TSHMR1, SMSMIX1, 817453EMMR1, 469846TSMMR1, 713929MR2, 281412MR1, 972712TINDMR1, 214214ABSMR1, 409729DHCMR1W, 972744TSRMR, 281341OBMR1, 972520TRSMR1, 210PINMRV, RADNETMR676, 210MSIPCV1, 210MSIPCV2, 210OICRV, 325574MRV, 713512MR1, 801377MR7, SMSUTA1, 801TANMR1, 801773MR2, 801SANPETEMR, 435EUSPMR, 435251VOY, 757312MRVOY, 757873MR, 804SPMR, 757707MR, INSIGHTMR1387, 253944SFMR, 206223VMR2, 206223VMR1, 425800MR, SMSVIT3, 920965MR1, 715330MR1, SMSWBI1, SMSWBI2, SMSVIT6, 414384VAMR1, SMSVIT2, SMSWES1, SHIMR02649, SMSWES3, SMSVIT8, SHIMR02642, 307630MR, 307755VMR, DZ2496MR01, DZ1820MR02, DZ1339MR05, DZ1090MR02, MR3755AR, MR6114AR, MR1836AR, MR2738AR, MR1518AR, 83169743687, 832MR000045, 832MR000028, 832MR000037, 832MR000047, 832MR000009, 83178031584, 834MR000034, 834MR000048, 834MR000036, 834MR000004, 833MR000018, 833MR000026, 833MR000007, 833MR000049, 833MR000022, AP6264MR02, MRPM0410, MR51339231, BY4120MR01, BY4075MR01, MRPM1143, MRRD0499, MR51028591, MRPM0249, MRPM1294, MRPM0790, MRRD0096, MRPM1193, MRPM0399, MRRD0259, MRRD0135, MRPM0592, MRRD0231, MRPM0566, MRPM0169A, MRRD0274, MRPM0972, MRRD0301, MRRD0224, MRPM0710, MRPM1256, MRPM1210, MRPM0656, MRRD0833, MRPM0452, MRRD0564, MRRD0364, MRRD0310, MRRD0773, MRRD0768, MRRD0492, MRRD0681, MRPM1212, MRRD0384, MRPM0803, MRRD0756, MRRD0202, MRRD0275, MRPM1186, MRRD0625, MRPM0955, MRPM1088, MRRD0932, MRPM1106, MRRD0129, MRRD0037, MRRD0368, MRRD0263, MRRD0105, MRPM0509, MRPM1257, MRRD0172, MRRD0712, MRRD0273, MRRD0079, MRPM1359, MRPM0920A, MRPM0878, MRPM0492, MRPM0304, MRRD0919, MRRD0719, MRRD0375, MRRD0244, MRRD0256, MRRD0206, MRRD0083, MRRD0038, MRRD0034, BG4786MR01, BG4853MR01, 6073MR0044, 6073MR0053, 6073MR0046, 780699MRV, 604675MOBMRV, 780612MRV, 403967MRV, 819563MR, 780679MRV, 450688MR1, 418653MR2, 306664MR1, 613283MR11, MR4243CL, 082427110138, 082427040313, 082427040321, 082427040326, 082427040331, 082427040241, 082427220142, 082427220135, 082427220107, 082427220088, 082427040315, 082427220110, 082427140307, 082427140202, 082427270088, 082427140267, 82427090504, 082427210249, 082427210240, 082427230255, 082427130112, 082427160336, 082427040266, 082427210203, 082427200193, 082427140209, 082427310146, 082427140217, 082427140213, 082427110111, 082427100391, 082427230189, 082427090376, 82427140341, 082427140301, 082427140251, 082427140214, 082427140191, 082427140198, 082427140231, 082427180057, 082427190181, 082427160297, 082427180056, 082427100414, 082427140227, 082427210225, 082427310144, 082427310139, 082427090387, 082427180058, 082427220129, 082427220098, 082427290060, 082427160322, 82427160428, 082427160330, 082427180059, 082427240116, 82427180087, 082427210220, 082427070232, 082427070252, 082427010190, 082427210260, 082427210216, 082427060110, 082427060101, 082427300034, 082427300037, 082427280032, 082427230203, 082427100510, 082427130127, 082427310138, 082427230208, 082427250102, 082427250135, 082427250120, 082427250134, 082427250130, 082427140289, 82427140339, 082427140321, 082427140211, 082427140335, 082427140234, 082427140258, 082427140218, 082427250128, 082427250113, 082427250126, 082427250127, 082427250119, 082427250114, 082427060109, 082427040310, 082427040327, 082427230162, 082427230210, 082427230215, 082427230217, 082427110109, 082427110121, 082427110114, 082427110116, 082427100475, 082427160404, 082427160309, 082427160296, 082427160304, 082427130139, 082427200169, 82427200236, 082427070323, 082427090418, 082427140300, 082427140336, 082427140338, 082427140322, 082427140248, 082427140278, 082427140265, 082427140257, 082427140193, 082427140343, 082427140273, 082427140249, 082427140216, 82427140331, 082427140288, 082427140241, 082427140252, 082427140194, 082427140235, 082427140195, 082427140222, 082427140259, 082427140206, 082427290045, 082427240092, 082427220089, 082427220095, MRPM0542, CS1027MR01, CS1090MR01, CS1328MR01, 600102MR01, DK1277MR02, DK1224MR01, DK1296MR02, DK1049MR01, DK1049MR02, MRPM0823, MRPM0361, MRRD0569, EG2982MR01, EG2707MR02, EG2707MR01, EG2676MR02, EG2131MR01, EG1795MR01, EG2939MR01, EG1525MR03, EG2849MR01, EG2563MR01, EG1542MR02, FI1012MR09, FI1012MR08, FI1015MR06, FI1530MR01, FI1003MR02, 9600192, X122205816, X151407614, 9524602, M4135328, X167162413, X240779701, 6249781, X628532201, MR52652781, GP1046MR03, 8953473, M4164357, M359673903, X868131021, 9974431, X706835020, M196514409, X669977019, X6002825, 9850617, 6211004, 8310782, 8880014, 8890678, M683032102, 8903130, 7296684, 7296685, 7310155, 9447001, X767340201, MR52305481, 8228707, 9721386, 8953472, 9672286, M511204701, M4438415, 6576447, M1425522, X102860309, 10025906, RE1197MR01, M5483014, X4184401, X185801212, 7143819, 8738801, M8321417, A5485280, M4187731, 8302064, 8912544, M429705301, X197096001, 8183586, 6825992, M2437608, A6023427, X255501005, X179963601, M4644049, 10005736, 8953464, 8363379, MR49413131, 6954494, 7023729, M160034205, 8953471, 8886546, 7960964, 8085680, M176430619, A9502030, M2863017, 7277820, 9495994, M2748230, 7448419, 7448420, X178710404, 8363378, 8270491, 8953465, 7951256, A4463352, F1669607, M682846501, 8089972, M477182002, 8106170, 6860447, 6260041, M1460214, M2850021, MR52650261, 8953467, 8953470, 7919523, MR52297861, M215631209, M386271503, X751964012, M2718174, M2718171, M2875118, M4433018, X4211069, 8532166, 7151482, 7034275, 6529145, M2228049, M2950014, 10047217, 7313350, X247551505, M136684818, B75162216, 8288087, M4216045, M1279753, 7861296, 7313558, X738353902, 8558934, GE1201MR01, PC1501MR02, 419729MR01, PC0075MR05, 113656MR01, 744459MR01, 221780MR04, CC0820MR13, 125528MR04, PC0233MR03, HC0114MR01, PC7343MR02, 160234MR02, 123701MR03, 477494MR01, PC0573MR04, PC2007MR03, TP0012MR02, 654076MR03, P00042MR03, HC1275MR01, 123740MR02, 852016MR01, 631515MR01, PC1961MR04, PC1961MR03, HC2862MR01, PC3817MR03, PC0304MR01, 118404MR02, 364839MR01, 477085MR01, HC3068MR02, 392574MR02, 125390MR02, PVIL01MR04, TP5555MR02, TP0575MR01, PC7590MR02, 168650MR01, 505458MR01, H44438MR03, H13491MR02, H10632MR17, H4478MR13, H7274MR01, H1066MR41, H1266MR13, H44439MR08, H10391MR18, H4443MR20, H5350MR14, H4145MR15, H47771MR19, H5049MR10, MRPM0705, 828270081, 0828270074, 0828270078, 0828270075, 0828270071, 0828270070, 0828270068, 0828270067, 0828270060, 828270076, 0828270066, 0828270061, 0828270057, 0828270054, HU1506MR01, HU1635MR01, HU1038MR04, HU1083MR02, HU1053MR01, HU1767MR01, HU1137MR01, HU1695MR01, 083027200941117, 083027809718817, 083027601763217, 7982MR0034, 7982MR0023, 7982MR0003, 7982MR0047, 7982MR0083, IR1288MR03, IR2616MR01, MR52387371, IQ1916MR01, IE1100MR03, IE1303MR01, IE1332MR01, IE1236MR01, IE1219MR01, IE1075MR03, IE1335MR01, 9610083, IE1334MRM1, IE1297MR01, 9877136, IL1062MR06, B5381867, A5714636, 9590090, A5360497, B5809217, 9584561, A141038605, B46832502, A171995615, K5345906, A5912924, A5170311, A5679107, A126322025, A468325104, 9065494, A104057306, A5810841, A5396913, A5141238, A223414521, B5123311, B5801754, A236501201, A5698025, A5158838, A5158841, A51149133, A208415217, A5379636, A5820187, A5820848, B5196801, A255888102, A5696703, 9553469, A5124405, A5331712, 9672284, A5229917, 9943704, A5769217, 9309518, A5196829, 9672288, A5226506, A51529240, A51529242, A228557101, C5618322, A56183194, A34802404, A5730007, A665033304, A665033301, B257027604, A5267111, B5201212, A5389824, A5671803, A5739718, A5191301, A5408631, A6195610, 10050105, A99155716, A5985917, A5174278, A5721921, ZC0316, MR00039, MR00130, ZC0206, MR00066, MR00159, MR00116, MR00028, MR00211, MR00109, MR00032, ZC0317, MR00105, ZC0320, MR00167, ZC0101, ZC0203, MR00064, ZC0310, ZC0311, ZC0205, MR00243, MR00232, MR00010, MR00186, ZC0210, ZC0107, MR00175, ZC0204, MR00129, ZC0106, MR00114, MR00188, MR00190, MR00007, MR00154, ZC0209, MR00100, MR00110, MR00094, MR00049, MR00084, ZC0104, MR00022, MR00083, ZC0201, ZC0105, ZC0103, MR00096, ZC0321, MR00102, ZC0102, ZC0202, MR00119, MR00150, JO4094MR01, JO4167MR01, JO4161MR01, KA2953MR01, 0850270741, 0850270774, 850270803, KW1198MR01, KW1144MR01, KW1189MR01, KW1002MR02, KW1146MR01, MR51916571, MR49467811, LV4058MR02, LV4002MR02, LV4038MR02, LB1519MR01, LB1493MR01, MR52924261, LB1537MR01, LB1039MR01, MR49219531, LT4110MR01, LT4001MR01, LT4006MR03, MR52002551, LT4122MR01, MC4035MR01, 1553MR0018, 1553MR0013, 1553MR0019, 1553MR0017, 1553MR0022, MRPM1060, MRPM0606, MRPM0394, MRPM1045, MRPM1066, MRPM0756, MRPM0660, MRPM0548A, MRPM0454, MRRD0406, MRRD0582, MA1421MR02, MAMR49502761, MR49502761, MR52293801, MA1884MR01, MR51168921, MA1690MR01, MA1002MR03, AAA01211, ZTM0427, 859MR000041, NO1136MR01, MR49896201, MR53436833, OM1013MR01, PK1365MR01, PK1548MR01, PK1003MR01, MRPM0614, 1557MR0036, 1557MR0047, 1557MR0032, 1557MR0025, P00575MR01, PL1732MR02, PL1310MR03, P00041MR01, PL0321MR01, PL1724MR02, PL3550MR02, P00525MR01, PL3677MR02, PL1394MR02, PL0580MR01, PL1178MR01, PL1797MR02, PL1502MR02, P00527MR01, P00605MR01, PL3528MR01, PL1007MR01, P00325MR01, P00326MR01, PL1640MR01, P00467MR01, P00467MR02, PL0195MR02, PL1822MR02, P00506MR01, P00212MR01, PL1600MR02, PL0660MR04, P00318MR01, PL0893MR02, PL2130MR02, PPS28212, PPS87300, PPS03714, PPR00614, PPS51800, PPS34700, PPS17703, MRPM0341, MRRD0617, MRPM0408, MRPM0075, QA1151MR01, MR51954063, RO1617MR01, RO1498MR01, RO1663MR01, RO1417MR01, RO1599MR01, RO1332MR01, RO1154MR02, RO1563MR01, RO1656MR01, RO1627MR01, RO1581MR01, RO1472MR01, RO1223MR03, RO1108MR03, RO1642MR01, RO1496MR01, RO1576MR01, RO1228MR02, RU2611MR01, RU8719MR01, RU3448MR01, RF2210MR01, RU3429MR02, RU1158MR02, RU7366MR01, RF2700MR01, RF3464MR01, RU7866MR01, RF3281MR01, RF0827MR01, RU3969MR01, RU1195MR02, RU3508MR03, RU3458MR01, RF2428MR01, RF0001MR02, RF3031MR01, RU7174MR01, RU1232MR01, RU1041MR03, RF1382MR01, RF0402MR02, RF0402MR01, RU8157MR01, 600130MR03, RF1908MR01, RF1908MR02, RU1838MR03, RU1591MR01, RF0931MR01, RF0159MR01, RF0723MR01, RF0830MR01, RU9227MR01, RF1085MR02, RU3116MR01, RU2371MR03, RF3117MR01, RU5231MR01, RU2407MR01, RF0358MR01, RU7182MR01, RU7130MR02, RU7316MR01, RU2167MR02, RU1047MR01, RF3141MR01, RU2636MR01, RF3230MR01, RU0928MR01, RF0240MR01, RU9357MR02, RU1139MR01, RU9226MR01, RU2679MR02, RU1173MR02, RU5495MR01, RU9595MR01, RU0968MR01, RU1457MR02, RU1718MR01, RU3469MR02, RU3467MR01, RU4815MR01, RU0099MR01, RU7258MR01, RU1298MR01, RU1999MR02, RU2669MR01, RU2453MR01, RU1263MR01, RF3352MR01, RU7866MR02, RU6591MR01, RU1138MR01, RF2412MR01, SA1216MR01, SA1137MR02, SA5006MR02, SA1089MR01, SA2291MR01, SA2980MR01, SA2939MR01, SA2743MR01, SA1013MR02, SA1325MR01, SA5002MR01, SA2133MR01, SA5000MR04, SA5000MR05, SA5001MR02, SA5003MR02, SA2982MR01, SA2454MR02, SA2973MR01, SA2744MR01, SA1017MR01, SA5004MR01, 6073MR0048, 6073MR0047, 6073MR0043, 6073MR0051, 6073MR0021, 9970967, ZA2713MR01, ZA2554MR02, DEN272132, GEX00703, GPQ18712, ME6459105, MPD30300, MPX84736, MPX70913, MPX84728, UP925719, UP925715, MP713129, NE212492, NE203173, FEB92541, NE2099246, NE670346, GEX01100, GEC21871, UPW07917, NPV69700, YP630027, DPN83504, DPB17723, DPN17104, DPN26345, FPG39205, NEV27546, FEG47529, ME751804, DPB27009, CE557073, GPX25919, YED00100, FPG57132, DPN63102, GPX45700, NPV31733, NE419193, NEV439247, NEV439245, NEV439252, NPV22538, CPZ35320, MP230742, YE600213, NPV59500, EPP04602, FP787602, NPD22300, O012MR03, Z001MR04, A188MR01, A375MR01, A013MR03, 120982MR01, 259130MR14, 265050MR06, 529110MR01, 249121MR01, 786090MR08, 529150MR02, 222768MR02, 0853270189, 853270221, 0853270230, 0853270222, 0853270186, 0853270219, 0853270226, 0853270193, 0853270190, 0853270182, 0853270176, 0853270210, 0853270206, 0853270187, 0853270211, 0853270168, 1573MR0070, 1573MR0059, 1573MR0068, 1573MR0030, 1573MR0031, 1573MR0049, 1573MR0039, 1573MR0048, 1573MR0032, 1573MR0067, MRPM1020, MRPM1110, MRRD0511, MR7468TT, 7733938, TN1744MR01, 01078MRS02, 06236MRS02, 06184MRS08, 72011MRS01, 34719MRS01, 34705MRS01, 9820443, 9820444, 35118MRS02, 35096MRS02, 35093MRS01, 8216527, 41054MRS01, 41009MRS01, 9843579, 54024MRS01, 06170MRS01, 34118MRS02, 9647471, 7772625, AE1492MR01, AE1675MR01, AE1785MR01, 7930698, 00617MRM02, IE1328MR01, 9083296, 9944179, 00417MRS02, 00243MRM01, 00243MRM02, 9555602, 00253MRS01, 10579MRS01, 01203MRS02, 9843583, 00365MRS01, 00380MRS01, 11033MRS01, 11414MRM01, 05271MRS02, 11287MRS01, 10100MRM20, 10100MRM16, 10100MRM18, 10100MRM19, 10100MRM17, 10100MRM15, 10100MRM14, 10100MRM01, 10100MRM12, 10100MRM11, 10100MRM10, 10100MRM09, 10100MRM05, 10100MRM04, 10100MRM06, 10100MRM07, 10100MRM02, 10100MRM03, 10044MRM01, 11708MRS02, 00289MRS03, 00289MRS04, 9793947, 11363MRM06, 11363MRM05, 11363MRM04, 11363MRM02, 11363MRM03, 11363MRM01, IE1326MR01, 10893MRM05, 9843581, 10893MRM04, 10893MRM03, 10893MRM02, 11710MRS01, 10699MRM05, 10007511, 00471MRS01, 00100MRS02, 9678333, 10541MRM01, 10127400, 11708MRS01, 11863MRS01, 11863MRS02, 11681MRM02, 10079MRM90, 10079MRM85, 10583MRM01, 10079MRM84, 10079MRM88, 10079MRM89, 10079MRM86, 13259, 203855VOYAGER, 863494MR, 813328MR, 904MBMR, 813977MR1, 404COMPETMR, 208356MR, 773296MR, 574335VOYAGER, 620792GBMR, 985690MR, 617754MR8, 617499MR4, RADNETMR1726, RADNETMR1728, 551214MR, 908351MRVOY, 908788MRVOY, SDMIADVMR2, SDMIBDVMR1, RADNETMR1729, 315SJIAVOY2, 315SJIAVOY, RADNETMR1717, 516340MR15T, 419538VOY, 803936LMCMR3, 605322MMR3, UTMBMOBMR1, 210681WHMR2, 210681WHMR1, 757596VOYMR, SHIMR02641, SHIMR02643, MRRD0515, MRRD0643, MR1663UY, MR6292UY, MR6253UY, 256386SHMR, RADNETMR688, SHIMR02655, 321CCMRVOY, ALOHAMR, SMSDOT1, 270746MR, 828315VOY, INSIGHTMR1417, 336472VOY, 845202MR, 945677MCMR, MHMOBILEMR2, 210SMAHMR, RADNETMR686, 804VETMR, DZ1015MR01, DZ2680MR02, 13065290, MR5467CR, 12227673, 12227677, 12227689, MRPM0938, MR55214861, 11524268, 11848196, MR54430831, MR54572231, MR53606561, MR53606571, 12750115, 12626589, 12159218, MRPM1331, MRPM1393, PHMRI24495634, PL2433MR02, 12743136, SA1420MR01, SA2973MR02, SA1031MR03, SA1213MR01, SGMRI24467792, 12132537, 12626575, 12559407, MR54585361, 09999947, 12357138, SMSBYT2, A6330406, PL1031MR03, 201796MR, 11259951, 11259952, FEG45951, 208251BINGMR (w/ DETACH FLO), 509925MR (w/ DETACH FLO), MRPM0407 (w/ FLO IPM), RADNETMR684 (w/ FLO IPM), 0853270227(w/ FLO IPM), 06516150 (W/ TJS IPM), 833MR000044 (W/ ARES FLO FIXED).

Distribution pattern

Worldwide distribution.

device · product 13 of 26

1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2471-2024
Recall number
Z-2471-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
2146 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 907373VMR, 256SPMR2, 870642MR, 5340995MR11, KRMCMR2, SMSCIA2, 714229MR2, SHIMR02637, 310358VMR, RADNETMR664, 559447MRVOYA3, 559447MRVOYA2, 559447MRVOYA1, INSIGHTMR1397, 626359VMR4, INSIGHTMR1371, ALLIANCEVOYA04, 707431MR, 323294VMR, 310823VMR, SHIMR02636, 818496HCMR1, 209SUTBMR, SHIMR02625, SHIMR02617, 530OROMMR, SHIMR02645, INSIGHTMR1385, INSIGHTMR1378, SHIMR02647, 13412, SHIMR02648, SHIMR02635, SHIMR02654, RADNETMR648, SHIMR02639, ALLIANCEVOYA11, INSIGHTMR1376, SHIMR02650, SHIMR02638, SHIMR02624, 818708MR2, 707462VOYMR, 661HMVMR1, 760247VMR, SHIMR02653, 303750MR, 307630MR2, 719394MR, 970242VAMR, 3036140MR, 720513MR, 970879VMR, 860289VOYAGER, 860659MRVOYAGER, 203453VOYAGER, 860347VOYAGER, 203834VOYAGER, 302655MR1, 561996MR1, 813315MR, 352597MR1, ALLIANCEVOYA01, 305445MR1, 904CSMR, 904627MR3, SHIMR02652, 321CLMRVOY, 305229MR1, 239NHVOY, 352ADVMR, 352867MR2, 941MPGPGVOY, 813655MR, 813874MR1, 941VOYMR, 850325MR1, 850877MR1, 229758MRI, 770539MR, MSF138-1-6XIAHPU7, 478745VMR, 229329MRI, SMSVIT7, SMSSVM8, SMSZOE3, SMSKIT1, SMSSVM1, SMSMAG1, SMSCAM2, SMSAMP1, SMSOMR1, 712737MRVOY, SMSWES4, 319352MR, SMSOAK2, 208735VOYMR, SMSCIA1, SHIMR2667, 618GOSHENMR, 847931MR, DSSMR5, SMSCAM1, 1000003628, 217QMGVOYAGER, SMSOMR5, 847252MRI, SMGMR59, DMSMR166, SMSZAG1, 812348MR2, 317415VOY, 574537MR, 574647VOYAGER, 574271MR, 812663MR2, 317899MR, 812283MR, SMSOMR2, SMSSVM4, SMSSVM3, 316613MR, 606833MRW2, DSSMR6, 606598MR2, 985ONCMR2, 4600722-MSF116-1-1-1, 985FWMR, SMGMR44, 337593VOYAGER1, 337470MR1, 318251GCVOYAGER, 978922MR, NBHMOBILEMR2, 617789MR, 508548MR1, 508825MR1, 781952MR, RADNETMR1712, RADNETMR1701, 301618MR1, 269979VOY, 248VOY, SJMOBILE, ALLIANCEVOYA10, 586263VOYA1, 248553VOYAGER, 810732VOYAGER, 906483VOYA, ALLIANCEVOYA03, ALLIANCEVOYA02, 269342VOY, 517VOY2, RMIMOBILEMR, ALLIANCEVOYA06, ALLIANCEVOYA08, 989583VOYMOB, ALLIANCEVOYA09, 952738MR1, SMSVIT1, 507537MRVOY, 612RICMR, 507825MRVOY, 320255VOY, 651747VOY1, WC231MR, SMSVIA1, SMSSVM2, 417891MR1, 601936VMR, 662377VOYMR1, 601883VMR, 406237TMR, 406587BOMR, 406455MR2, 406445CMR, 406449BMR1, 406751MMR, BPMOBILEMR12, BPMOBILEMR11, 828250VOYAGERMR, 828213MHMR, 4975485MR11, 704820VOYA, 704323MOB1, 704831CNMR2, MQ29NORFOLK, 704697VOYA, TRANSTATEMR1, 704783VOY, 980212MR, 704834VOY, 828681AHMR, 704895VOY, 980993VOYA, 252OBHMR, ALLIANCEVOYA05, 828766BRMR, 704CISMOB3, 910CRVOY, 701444MR, SMSWAY1, SMSSVM5, SMSOAK3, SMSKIT2, 402336VMR, MOB14GEMR, RADNETMR1693, SHIMR02618, ATLHLTHCLK, 732497MRVOY, 609597MRVOY, 973370MR, 732988MRVOY, 201261MR, 973837MR, LARCHVOYAGER, PMIM122MR, 775827NRHPMR, 518262VOYAGER, 518438MR2, 716250MR, ALLIANCEVOYA07, 718613MR, 718963MR, 716204VMR1, 716250VMR1, 585NOYESMR, 516GCVOY, 607535MR, 716217MR, 607337MR, 631758MR, 607865MR, 585716JONESMR, 631998MR, 914962MRI, 330AULTMR1, 330AULTMR1B, 330MMCM1, 724029MR1, 330AULTMR1A, 513793MR, 937236MR, 330AULTMR1D, MHKMMR1, 513424KHMR, 724029MR2, 740991MRW, WCOHC3, MHSPRGEMR1, 419933MR, 405224GMR, 580354MVMR, 405230MR, SMGMR46, 405749OSMR, SMSSVM6, 405273PMR, 405743MR, 918523MR3, 918940MR1, 405350MR, 541383MR, 541472VMR, 610402MR, 610317MR1, 717761MR3, 814624MR, 484498MR, 484224MR, 835215MR, SHIMR02646, 215707VOYAGER, 570621MR, SMGMR56, 570307MR1, 717765MR, 401793MR, 803936LMCMR4, 864229MRI, 843716MRV, 843236CFVOY, 803992VOY, 803936LMCMR1, 605217MRVOY, 605598MRVOY, SMSOAK1, 423697MR2, 423697MR1, 615WBJMR1, 615986HVPR, 865584MR2, 901516VOY, 806212VMR30, 817358HCABMR1, 713314MHOPM, 817293HMR1, 469221ADHMR1, 817294TSWMR1, 713451VOY1, 281955MR1, 713778MR1, 832658MHMR1, 817498TSHMR1, SMSMIX1, 817453EMMR1, 469846TSMMR1, 713929MR2, 281412MR1, 972712TINDMR1, 214214ABSMR1, 409729DHCMR1W, 972744TSRMR, 281341OBMR1, 972520TRSMR1, 210PINMRV, RADNETMR676, 210MSIPCV1, 210MSIPCV2, 210OICRV, 325574MRV, 713512MR1, 801377MR7, SMSUTA1, 801TANMR1, 801773MR2, 801SANPETEMR, 435EUSPMR, 435251VOY, 757312MRVOY, 757873MR, 804SPMR, 757707MR, INSIGHTMR1387, 253944SFMR, 206223VMR2, 206223VMR1, 425800MR, SMSVIT3, 920965MR1, 715330MR1, SMSWBI1, SMSWBI2, SMSVIT6, 414384VAMR1, SMSVIT2, SMSWES1, SHIMR02649, SMSWES3, SMSVIT8, SHIMR02642, 307630MR, 307755VMR, DZ2496MR01, DZ1820MR02, DZ1339MR05, DZ1090MR02, MR3755AR, MR6114AR, MR1836AR, MR2738AR, MR1518AR, 83169743687, 832MR000045, 832MR000028, 832MR000037, 832MR000047, 832MR000009, 83178031584, 834MR000034, 834MR000048, 834MR000036, 834MR000004, 833MR000018, 833MR000026, 833MR000007, 833MR000049, 833MR000022, AP6264MR02, MRPM0410, MR51339231, BY4120MR01, BY4075MR01, MRPM1143, MRRD0499, MR51028591, MRPM0249, MRPM1294, MRPM0790, MRRD0096, MRPM1193, MRPM0399, MRRD0259, MRRD0135, MRPM0592, MRRD0231, MRPM0566, MRPM0169A, MRRD0274, MRPM0972, MRRD0301, MRRD0224, MRPM0710, MRPM1256, MRPM1210, MRPM0656, MRRD0833, MRPM0452, MRRD0564, MRRD0364, MRRD0310, MRRD0773, MRRD0768, MRRD0492, MRRD0681, MRPM1212, MRRD0384, MRPM0803, MRRD0756, MRRD0202, MRRD0275, MRPM1186, MRRD0625, MRPM0955, MRPM1088, MRRD0932, MRPM1106, MRRD0129, MRRD0037, MRRD0368, MRRD0263, MRRD0105, MRPM0509, MRPM1257, MRRD0172, MRRD0712, MRRD0273, MRRD0079, MRPM1359, MRPM0920A, MRPM0878, MRPM0492, MRPM0304, MRRD0919, MRRD0719, MRRD0375, MRRD0244, MRRD0256, MRRD0206, MRRD0083, MRRD0038, MRRD0034, BG4786MR01, BG4853MR01, 6073MR0044, 6073MR0053, 6073MR0046, 780699MRV, 604675MOBMRV, 780612MRV, 403967MRV, 819563MR, 780679MRV, 450688MR1, 418653MR2, 306664MR1, 613283MR11, MR4243CL, 082427110138, 082427040313, 082427040321, 082427040326, 082427040331, 082427040241, 082427220142, 082427220135, 082427220107, 082427220088, 082427040315, 082427220110, 082427140307, 082427140202, 082427270088, 082427140267, 82427090504, 082427210249, 082427210240, 082427230255, 082427130112, 082427160336, 082427040266, 082427210203, 082427200193, 082427140209, 082427310146, 082427140217, 082427140213, 082427110111, 082427100391, 082427230189, 082427090376, 82427140341, 082427140301, 082427140251, 082427140214, 082427140191, 082427140198, 082427140231, 082427180057, 082427190181, 082427160297, 082427180056, 082427100414, 082427140227, 082427210225, 082427310144, 082427310139, 082427090387, 082427180058, 082427220129, 082427220098, 082427290060, 082427160322, 82427160428, 082427160330, 082427180059, 082427240116, 82427180087, 082427210220, 082427070232, 082427070252, 082427010190, 082427210260, 082427210216, 082427060110, 082427060101, 082427300034, 082427300037, 082427280032, 082427230203, 082427100510, 082427130127, 082427310138, 082427230208, 082427250102, 082427250135, 082427250120, 082427250134, 082427250130, 082427140289, 82427140339, 082427140321, 082427140211, 082427140335, 082427140234, 082427140258, 082427140218, 082427250128, 082427250113, 082427250126, 082427250127, 082427250119, 082427250114, 082427060109, 082427040310, 082427040327, 082427230162, 082427230210, 082427230215, 082427230217, 082427110109, 082427110121, 082427110114, 082427110116, 082427100475, 082427160404, 082427160309, 082427160296, 082427160304, 082427130139, 082427200169, 82427200236, 082427070323, 082427090418, 082427140300, 082427140336, 082427140338, 082427140322, 082427140248, 082427140278, 082427140265, 082427140257, 082427140193, 082427140343, 082427140273, 082427140249, 082427140216, 82427140331, 082427140288, 082427140241, 082427140252, 082427140194, 082427140235, 082427140195, 082427140222, 082427140259, 082427140206, 082427290045, 082427240092, 082427220089, 082427220095, MRPM0542, CS1027MR01, CS1090MR01, CS1328MR01, 600102MR01, DK1277MR02, DK1224MR01, DK1296MR02, DK1049MR01, DK1049MR02, MRPM0823, MRPM0361, MRRD0569, EG2982MR01, EG2707MR02, EG2707MR01, EG2676MR02, EG2131MR01, EG1795MR01, EG2939MR01, EG1525MR03, EG2849MR01, EG2563MR01, EG1542MR02, FI1012MR09, FI1012MR08, FI1015MR06, FI1530MR01, FI1003MR02, 9600192, X122205816, X151407614, 9524602, M4135328, X167162413, X240779701, 6249781, X628532201, MR52652781, GP1046MR03, 8953473, M4164357, M359673903, X868131021, 9974431, X706835020, M196514409, X669977019, X6002825, 9850617, 6211004, 8310782, 8880014, 8890678, M683032102, 8903130, 7296684, 7296685, 7310155, 9447001, X767340201, MR52305481, 8228707, 9721386, 8953472, 9672286, M511204701, M4438415, 6576447, M1425522, X102860309, 10025906, RE1197MR01, M5483014, X4184401, X185801212, 7143819, 8738801, M8321417, A5485280, M4187731, 8302064, 8912544, M429705301, X197096001, 8183586, 6825992, M2437608, A6023427, X255501005, X179963601, M4644049, 10005736, 8953464, 8363379, MR49413131, 6954494, 7023729, M160034205, 8953471, 8886546, 7960964, 8085680, M176430619, A9502030, M2863017, 7277820, 9495994, M2748230, 7448419, 7448420, X178710404, 8363378, 8270491, 8953465, 7951256, A4463352, F1669607, M682846501, 8089972, M477182002, 8106170, 6860447, 6260041, M1460214, M2850021, MR52650261, 8953467, 8953470, 7919523, MR52297861, M215631209, M386271503, X751964012, M2718174, M2718171, M2875118, M4433018, X4211069, 8532166, 7151482, 7034275, 6529145, M2228049, M2950014, 10047217, 7313350, X247551505, M136684818, B75162216, 8288087, M4216045, M1279753, 7861296, 7313558, X738353902, 8558934, GE1201MR01, PC1501MR02, 419729MR01, PC0075MR05, 113656MR01, 744459MR01, 221780MR04, CC0820MR13, 125528MR04, PC0233MR03, HC0114MR01, PC7343MR02, 160234MR02, 123701MR03, 477494MR01, PC0573MR04, PC2007MR03, TP0012MR02, 654076MR03, P00042MR03, HC1275MR01, 123740MR02, 852016MR01, 631515MR01, PC1961MR04, PC1961MR03, HC2862MR01, PC3817MR03, PC0304MR01, 118404MR02, 364839MR01, 477085MR01, HC3068MR02, 392574MR02, 125390MR02, PVIL01MR04, TP5555MR02, TP0575MR01, PC7590MR02, 168650MR01, 505458MR01, H44438MR03, H13491MR02, H10632MR17, H4478MR13, H7274MR01, H1066MR41, H1266MR13, H44439MR08, H10391MR18, H4443MR20, H5350MR14, H4145MR15, H47771MR19, H5049MR10, MRPM0705, 828270081, 0828270074, 0828270078, 0828270075, 0828270071, 0828270070, 0828270068, 0828270067, 0828270060, 828270076, 0828270066, 0828270061, 0828270057, 0828270054, HU1506MR01, HU1635MR01, HU1038MR04, HU1083MR02, HU1053MR01, HU1767MR01, HU1137MR01, HU1695MR01, 083027200941117, 083027809718817, 083027601763217, 7982MR0034, 7982MR0023, 7982MR0003, 7982MR0047, 7982MR0083, IR1288MR03, IR2616MR01, MR52387371, IQ1916MR01, IE1100MR03, IE1303MR01, IE1332MR01, IE1236MR01, IE1219MR01, IE1075MR03, IE1335MR01, 9610083, IE1334MRM1, IE1297MR01, 9877136, IL1062MR06, B5381867, A5714636, 9590090, A5360497, B5809217, 9584561, A141038605, B46832502, A171995615, K5345906, A5912924, A5170311, A5679107, A126322025, A468325104, 9065494, A104057306, A5810841, A5396913, A5141238, A223414521, B5123311, B5801754, A236501201, A5698025, A5158838, A5158841, A51149133, A208415217, A5379636, A5820187, A5820848, B5196801, A255888102, A5696703, 9553469, A5124405, A5331712, 9672284, A5229917, 9943704, A5769217, 9309518, A5196829, 9672288, A5226506, A51529240, A51529242, A228557101, C5618322, A56183194, A34802404, A5730007, A665033304, A665033301, B257027604, A5267111, B5201212, A5389824, A5671803, A5739718, A5191301, A5408631, A6195610, 10050105, A99155716, A5985917, A5174278, A5721921, ZC0316, MR00039, MR00130, ZC0206, MR00066, MR00159, MR00116, MR00028, MR00211, MR00109, MR00032, ZC0317, MR00105, ZC0320, MR00167, ZC0101, ZC0203, MR00064, ZC0310, ZC0311, ZC0205, MR00243, MR00232, MR00010, MR00186, ZC0210, ZC0107, MR00175, ZC0204, MR00129, ZC0106, MR00114, MR00188, MR00190, MR00007, MR00154, ZC0209, MR00100, MR00110, MR00094, MR00049, MR00084, ZC0104, MR00022, MR00083, ZC0201, ZC0105, ZC0103, MR00096, ZC0321, MR00102, ZC0102, ZC0202, MR00119, MR00150, JO4094MR01, JO4167MR01, JO4161MR01, KA2953MR01, 0850270741, 0850270774, 850270803, KW1198MR01, KW1144MR01, KW1189MR01, KW1002MR02, KW1146MR01, MR51916571, MR49467811, LV4058MR02, LV4002MR02, LV4038MR02, LB1519MR01, LB1493MR01, MR52924261, LB1537MR01, LB1039MR01, MR49219531, LT4110MR01, LT4001MR01, LT4006MR03, MR52002551, LT4122MR01, MC4035MR01, 1553MR0018, 1553MR0013, 1553MR0019, 1553MR0017, 1553MR0022, MRPM1060, MRPM0606, MRPM0394, MRPM1045, MRPM1066, MRPM0756, MRPM0660, MRPM0548A, MRPM0454, MRRD0406, MRRD0582, MA1421MR02, MAMR49502761, MR49502761, MR52293801, MA1884MR01, MR51168921, MA1690MR01, MA1002MR03, AAA01211, ZTM0427, 859MR000041, NO1136MR01, MR49896201, MR53436833, OM1013MR01, PK1365MR01, PK1548MR01, PK1003MR01, MRPM0614, 1557MR0036, 1557MR0047, 1557MR0032, 1557MR0025, P00575MR01, PL1732MR02, PL1310MR03, P00041MR01, PL0321MR01, PL1724MR02, PL3550MR02, P00525MR01, PL3677MR02, PL1394MR02, PL0580MR01, PL1178MR01, PL1797MR02, PL1502MR02, P00527MR01, P00605MR01, PL3528MR01, PL1007MR01, P00325MR01, P00326MR01, PL1640MR01, P00467MR01, P00467MR02, PL0195MR02, PL1822MR02, P00506MR01, P00212MR01, PL1600MR02, PL0660MR04, P00318MR01, PL0893MR02, PL2130MR02, PPS28212, PPS87300, PPS03714, PPR00614, PPS51800, PPS34700, PPS17703, MRPM0341, MRRD0617, MRPM0408, MRPM0075, QA1151MR01, MR51954063, RO1617MR01, RO1498MR01, RO1663MR01, RO1417MR01, RO1599MR01, RO1332MR01, RO1154MR02, RO1563MR01, RO1656MR01, RO1627MR01, RO1581MR01, RO1472MR01, RO1223MR03, RO1108MR03, RO1642MR01, RO1496MR01, RO1576MR01, RO1228MR02, RU2611MR01, RU8719MR01, RU3448MR01, RF2210MR01, RU3429MR02, RU1158MR02, RU7366MR01, RF2700MR01, RF3464MR01, RU7866MR01, RF3281MR01, RF0827MR01, RU3969MR01, RU1195MR02, RU3508MR03, RU3458MR01, RF2428MR01, RF0001MR02, RF3031MR01, RU7174MR01, RU1232MR01, RU1041MR03, RF1382MR01, RF0402MR02, RF0402MR01, RU8157MR01, 600130MR03, RF1908MR01, RF1908MR02, RU1838MR03, RU1591MR01, RF0931MR01, RF0159MR01, RF0723MR01, RF0830MR01, RU9227MR01, RF1085MR02, RU3116MR01, RU2371MR03, RF3117MR01, RU5231MR01, RU2407MR01, RF0358MR01, RU7182MR01, RU7130MR02, RU7316MR01, RU2167MR02, RU1047MR01, RF3141MR01, RU2636MR01, RF3230MR01, RU0928MR01, RF0240MR01, RU9357MR02, RU1139MR01, RU9226MR01, RU2679MR02, RU1173MR02, RU5495MR01, RU9595MR01, RU0968MR01, RU1457MR02, RU1718MR01, RU3469MR02, RU3467MR01, RU4815MR01, RU0099MR01, RU7258MR01, RU1298MR01, RU1999MR02, RU2669MR01, RU2453MR01, RU1263MR01, RF3352MR01, RU7866MR02, RU6591MR01, RU1138MR01, RF2412MR01, SA1216MR01, SA1137MR02, SA5006MR02, SA1089MR01, SA2291MR01, SA2980MR01, SA2939MR01, SA2743MR01, SA1013MR02, SA1325MR01, SA5002MR01, SA2133MR01, SA5000MR04, SA5000MR05, SA5001MR02, SA5003MR02, SA2982MR01, SA2454MR02, SA2973MR01, SA2744MR01, SA1017MR01, SA5004MR01, 6073MR0048, 6073MR0047, 6073MR0043, 6073MR0051, 6073MR0021, 9970967, ZA2713MR01, ZA2554MR02, DEN272132, GEX00703, GPQ18712, ME6459105, MPD30300, MPX84736, MPX70913, MPX84728, UP925719, UP925715, MP713129, NE212492, NE203173, FEB92541, NE2099246, NE670346, GEX01100, GEC21871, UPW07917, NPV69700, YP630027, DPN83504, DPB17723, DPN17104, DPN26345, FPG39205, NEV27546, FEG47529, ME751804, DPB27009, CE557073, GPX25919, YED00100, FPG57132, DPN63102, GPX45700, NPV31733, NE419193, NEV439247, NEV439245, NEV439252, NPV22538, CPZ35320, MP230742, YE600213, NPV59500, EPP04602, FP787602, NPD22300, O012MR03, Z001MR04, A188MR01, A375MR01, A013MR03, 120982MR01, 259130MR14, 265050MR06, 529110MR01, 249121MR01, 786090MR08, 529150MR02, 222768MR02, 0853270189, 853270221, 0853270230, 0853270222, 0853270186, 0853270219, 0853270226, 0853270193, 0853270190, 0853270182, 0853270176, 0853270210, 0853270206, 0853270187, 0853270211, 0853270168, 1573MR0070, 1573MR0059, 1573MR0068, 1573MR0030, 1573MR0031, 1573MR0049, 1573MR0039, 1573MR0048, 1573MR0032, 1573MR0067, MRPM1020, MRPM1110, MRRD0511, MR7468TT, 7733938, TN1744MR01, 01078MRS02, 06236MRS02, 06184MRS08, 72011MRS01, 34719MRS01, 34705MRS01, 9820443, 9820444, 35118MRS02, 35096MRS02, 35093MRS01, 8216527, 41054MRS01, 41009MRS01, 9843579, 54024MRS01, 06170MRS01, 34118MRS02, 9647471, 7772625, AE1492MR01, AE1675MR01, AE1785MR01, 7930698, 00617MRM02, IE1328MR01, 9083296, 9944179, 00417MRS02, 00243MRM01, 00243MRM02, 9555602, 00253MRS01, 10579MRS01, 01203MRS02, 9843583, 00365MRS01, 00380MRS01, 11033MRS01, 11414MRM01, 05271MRS02, 11287MRS01, 10100MRM20, 10100MRM16, 10100MRM18, 10100MRM19, 10100MRM17, 10100MRM15, 10100MRM14, 10100MRM01, 10100MRM12, 10100MRM11, 10100MRM10, 10100MRM09, 10100MRM05, 10100MRM04, 10100MRM06, 10100MRM07, 10100MRM02, 10100MRM03, 10044MRM01, 11708MRS02, 00289MRS03, 00289MRS04, 9793947, 11363MRM06, 11363MRM05, 11363MRM04, 11363MRM02, 11363MRM03, 11363MRM01, IE1326MR01, 10893MRM05, 9843581, 10893MRM04, 10893MRM03, 10893MRM02, 11710MRS01, 10699MRM05, 10007511, 00471MRS01, 00100MRS02, 9678333, 10541MRM01, 10127400, 11708MRS01, 11863MRS01, 11863MRS02, 11681MRM02, 10079MRM90, 10079MRM85, 10583MRM01, 10079MRM84, 10079MRM88, 10079MRM89, 10079MRM86, 13259, 203855VOYAGER, 863494MR, 813328MR, 904MBMR, 813977MR1, 404COMPETMR, 208356MR, 773296MR, 574335VOYAGER, 620792GBMR, 985690MR, 617754MR8, 617499MR4, RADNETMR1726, RADNETMR1728, 551214MR, 908351MRVOY, 908788MRVOY, SDMIADVMR2, SDMIBDVMR1, RADNETMR1729, 315SJIAVOY2, 315SJIAVOY, RADNETMR1717, 516340MR15T, 419538VOY, 803936LMCMR3, 605322MMR3, UTMBMOBMR1, 210681WHMR2, 210681WHMR1, 757596VOYMR, SHIMR02641, SHIMR02643, MRRD0515, MRRD0643, MR1663UY, MR6292UY, MR6253UY, IR1914MR01, 06073MRs01, 330334MR, 201773MR, 083027208277419, 083027601000510.

Distribution pattern

Worldwide distribution.

device · product 14 of 26

SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2472-2024
Recall number
Z-2472-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
1817 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 479397NUTEX, 407PRMDMR, 828210VETMR, DZ3736MR01, DZ3048MR01, DZ3898MR01, DZ1033MR03, DZ2763MR01, DZ2416MR01, DZ1174MR01, DZ4681MR01, MR9988AR, MR4790AR, MR4652AR, MR2498AR, MR9874AR, MR9143AR, MRR10900, MR6013AR, MR1950AR, MR3050AR, MR8927AR, MR7221AR, MR9664AR, MR6931AR, MR3104AR, MR3642AR, AM1032MR01, 83194404670, 083027608484817, 083027603618122, 083027600102223, 083027600101523, 083027602480921, 083027601272821, 083027600102423, BA4188MR01, BW6016MR01, MRR5332, MRR4141, MRR6531A, MRRD0604, MRR2844, MRRD0991, MRR3439, MRR5861, MRRD1097, MRR5800, MRR3997, MRR4316, MRR1175, MRRD366, MRR10976, MRR049, MRR11573, MRR11608, MRR2667, MRR10693A, MRR11288, MRR7419, MRR5942, MRR7312, MRRD0685, MRRD0627, MRRD0381, MRR3619, MRRD0341, MRRD0494, MRR10881, MRRD0521, MRRD0671, MRR4146, MRR5666, MRR3673, MRR1940, MRR11258, MRRD1049, MRRD0476, MRR11477, MRRD0971, MRR3777, MRR7385, MRRD1008, MRR2924, MRR2459, MRRD1171, MRRD0840, MRR3579, MRR974, MRR1555, MRRD1027, MRRD0570, MRRD0751, 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1553MR0014, MRR5629, MRRD1007, MRR7040, MRR4068, MRRD0654, MRR11209A, MRRD1183, MRR11495, MRR3789A, MRRD1142, MRR1004, MRR10780, MRR4983, MRR108, MRR3530, MRR985, MRR11628, MR006784TA3, MRG2KS17002, MRR050, MRRD0400, MRR6425, MRRD1108, MRG2KS17007, MRR2675, MRR3242, MRRD0370, MRCRE1800016TJ, MRG2KS17006, MRR8692, MRR3785, MRR2802, MRRD1331, MRR3970, MRRD0280, MRR3525, MMRR1726, MRR2632, MRRD0464, MRRD0348, MRRD1090, MRR4544A, MRR11225, MRRD0682, MRR7759, MRRD0986, MRR1026, MRRD0661, MRR2295, MRR4854, MRRD0703, MRRD0398, MRR11313, MRR11719, MRR318, MRR3171, MRR2208, MRR2938, MRCRE1800105TJ, MRRD0903, MRR1170, MRR2744, MRR5020, MRRD0949, MRR2814, MRYR2088, MRRD1043, MRR11272, MRR8159, MRRD0283, MRRD0985, MRR5373, MRR370A, MRR2860, MRRD1197, MRRD0638, MRR2508, MRR1182, MRRD1138, MRR4434, MRRD0340, MRR11043, MRRD1126, MRRD1204, MRR3419, MRR3182, MD1096MR01, 082427320004, ME3002MR02, MR50565031, MR50760571, MA1908MR01, MA1841MR01, MAMR50565031, MR51359651, MA1214MR01, MA1883MR01, MA1780MR01, MA1268MR01, MA1540MR01, MA1493MR01, MR50547781, MR52294081, MA1548MR01, MA1651MR01, MA1527MR01, MA1472MR01, MA1581MR01, MA1574MR01, MA1895MR01, MA1528MR01, MA1516MR01, MR52673071, MA1649MR01, MR52673261, MR49897611, MA1668MR01, 6073MR0039, 083027006963718, 083027001117523, 083027005964822, 083027000767723, 083027000768323, 083027006234424, 083027001417122, 083027006246519, 083027003379023, 083027002672317, MR52574901, NG1746MR01, NG1048MR01, NG1868MR01, NG1430MR01, NG1704MR01, NG1171MR01, NG1876MR01, NG1853MR01, NG1377MR01, NG1743MR01, 8607632, MR51274611, 8718381, NG1333MR01, NG1702MR01, NG1978MR01, NG1951MR01, NG1745MR01, NG1880MR01, NG1144MR01, 8807712, NG1991MR01, NG1958MR01, NG1796MR01, NG1843MR01, NG1434MR01, NG1042MR02, OM1087MR01, MR51128743, MR50241901, MR51992191, MR53130881, PA1099MR01, MRR5157, MR7765PY, MR2317PY, MR6843PE, MRRD1070, MRRD0731A, MR3773PE, MR1645PE, 1557MR0006, 1557MR0009, 1557MR0026, 1557MR0014, 1557MR0019, 1557MR0029, 1557MR0048, 1557MR0008, 1557MR0031, 1557MR0062, 1557MR0024, 1557MR0027, 1557MR0035, 1557MR0039, 1557MR0028, 1557MR0015, 1557MR0042, 1557MR0063, 1557MR0055, 1557MR0040, 1557MR0023, 1557MR0054, 1557MR0046, PL0320MR01, PL0620MR01, PL3500MR01, PL0467MR01, PL0068MR01, PL3886MR01, PL0064MR01, PL3544MR02, PL3697MR01, PL0588MR01, PL0130MR01, PL3548MR01, PL3625MR01, PL3623MR01, PL0250MR01, PL0439MR01, PL0003MR01, PL3696MR01, PL3595MR01, PL0636MR01, PL0065MR01, PL1778MR01, PL3885MR01, PL1840MR01, PL0286MR01, PL1063MR01, PL3794MR01, PL0083MR01, PL0281MR01, PL0657MR01, PL3810MR01, PPS32605, PPS16207, MR8084PR, MRR1448, MR4980PR, MRR6279, MRR2728, MRR3155, RO1523MR01, RO1424MR01, RO1588MR01, RO1311MR01, RO1511MR01, RO1118MR02, RO1236MR01, RO1629MR01, RO1530MR01, RO1459MR01, RO1506MR01, RO1508MR03, RO1508MR02, RO1114MR01, RU2283MR01, RU9636MR01, RU7742MR01, RU3152MR01, RF1194MR01, RU7746MR01, RU6350MR01, RU3137MR01, RU1228MR01, RU0002MR01, RF0314MR01, RU5488MR01, RU3022MR01, RU1826MR01, RU3232MR01, RU6265MR01, RU0164MR02, RU4468MR01, RU0003MR01, RU3158MR01, RF0211MR01, RU2235MR01, RU7612MR02, RU9105MR01, RU1242MR01, RF0062MR01, RU2711MR01, RU1757MR01, RU4355MR01, RU1117MR01, RU8271MR01, RU6890MR01, RU7310MR01, RU3639MR01, RU0731MR01, RF1053MR01, RF1203MR01, RU3192MR01, RU3315MR01, RU7447MR01, RF0196MR01, RU9155MR03, RF1075MR01, RU9320MR01, RU5475MR01, RU0441MR01, RU1339MR01, RU1140MR01, RF0771MR01, RF2928MR01, RU0476MR01, RU7579MR01, RU0658MR01, RU4670MR01, RU1820MR03, RF2395MR01, RU8782MR01, RU3930MR01, RU8778MR01, RU1266MR01, RU1810MR01, RU2010MR01, RF0328MR01, RU2445MR01, RU1030MR02, RU2047MR01, MR50188321, RW1049MR01, SA2677MR01, SA2712MR01, SA2425MR01, SA2846MR01, SA2859MR01, SA2760MR01, SA1231MR02, SA2468MR01, SA1043MR02, SA1064MR02, 6073MR0050, 6073MR0057, 6073MR0056, ZA3062MR01, ZA3061MR01, ZA2878MR01, ZA3263MR01, ZA1451MR01, ZA2669MR01, DPN85207, NPV62500, MPX51400, FPG86456, DPN29025, NPV60100, NPV58600, YP602101, CPZ13807, GPX37401, UE743A02, YP096106, FPG40900, DP596308, NPV74501, SZ0001MR01, 0853270163, 0853270229GS, 1573MR0071, 1573MR0074, 1573MR0025, 1573MR0044, 1573MR0029, 1573MR0046, 1573MR0016, 1573MR0035, 1573MR0018, 1573MR0037, 1573MR0038, 1573MR0021, 1573MR0008, 1573MR0052, 1573MR0020, 1573MR0003, 1573MR0040, MR9345TT, 01053MRS01, 01054MRS01, 04009MRS01, AE1630MR01, AE1557MR01, AE1149MR02, UZ3009MR01, UZ1099MR01, UZ1321MR01, MR51310811, UZ1018MR01, UZ1001MR04, UZ1353MR01, UZ1063MR01, UZ1320MR01, UZ1085MR01, MR51310631, MRR376, 5973MR0032, 5973MR0104, 5973MR0090, 5973MR0024, 5973MR0012, 5973MR0063, 5973MR0014, 5973MR0031, 5973MR0068, 5973MR0047, 5973MR0097, 9830MR0112, 5973MR0091, 5973MR0076, 5973MR0050, 5973MR0015, 5973MR0075, 5973MR0053, 5973MR0100, 9830MR0114, 5973MR0095, 5973MR0087, 5973MR0079, 5973MR0077, 5973MR0069, 5973MR0051, 5973MR0054, 5973MR0011, 5973MR0060, 5973MR0052, 5973MR0027, 5973MR0042, 5973MR0025, 5973MR0016, 5973MR0083, 5973MR0064, 5973MR0094, 5973MR0023, 5973MR0022, 5973MR0028, 5973MR0026, 5973MR0040, 5973MR0081, 5973MR0080, 5973MR0096, 5973MR0088, 5973MR0099, 5973MR0101, 5973MR0106, 5973MR0107, 5973MR0109, 5973MR0103, 5973MR0072, 5973MR0067, 5973MR0055, 9830MR0111, 9830MR0117, 5973MR0086, 5973MR0089, 9830MR0113, 5973MR0061

Distribution pattern

Worldwide distribution.

device · product 15 of 26

SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2473-2024
Recall number
Z-2473-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
2528 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: K2308, SHIMR02644, 415723SHMR6, 951682MR, 619291MR1, 2533, 303355MR, 305682MR1, 727869MR, 352344MR2, 407PIMRKCH, 630332MR, 316689MR, 508746JMR2, 406863WMR, 445MR2, 718567MR, 718250MR, 716839MR1, MSF094-1-6UQ9H2TJ, 412784MR1, 830643MMR2, 540776MR2, 360582450WPA, MSF094-1-6VI2CR9B, 630843OSCMR, AL4093MR01, DZ1638MR02, DZ2685MR01, DZ1930MR01, DZ4483MR01, DZ2684MR01, DZ2183MR01, DZ3053MR01, DZ1947MR01, DZ1305MR01, DZ1863MR01, DZ1035MR03, DZ1004MR03, DZ1004MR02, DZ4258MR01, DZ1601MR01, DZ1146MR01, DZ1504MR01, DZ1269MR01, DZ4165MR01, DZ3484MR01, DZ1339MR04, DZ1070MR01, DZ4047MR01, DZ2417MR01, DZ2418MR01, DZ3741MR01, DZ4609MR01, DZ2090MR01, DZ2785MR01, DZ2552MR01, DZ3365MR01, DZ4149MR01, DZ3445MR01, DZ1149MR02, DZ1337MR01, DZ2622MR01, DZ1268MR01, DZ3165MR01, DZ4313MR01, DZ1406MR03, DZ1771MR01, DZ1406MR02, DZ2092MR01, DZ1027MR01, DZ2014MR01, DZ1060MR05, DZ1297MR01, DZ2764MR01, DZ4227MR01, DZ2773MR01, DZ3805MR01, DZ2351MR01, DZ1475MR01, DZ1908MR01, DZ2361MR01, DZ1856MR02, DZ4929MR01, DZ3953MR01, DZ3078MR01, DZ2995MR01, DZ1255MR01, DZ4380MR01, DZ3087MR01, DZ1466MR01, MR3766AR, MR1946AR, MR9321AR, MR3338AR, 2722SIGNA15, MR3867AR, MR2812AR, MR6472AR, MR1196AR, MR8785AR, MR4330AR, MR8126AR, MR3498AR, MR8882AR, MR5700AR, MR6883AR, MR6459AR, MR7206AR, MR6816AR, MR8830AR, 4365SIGNA15, MR6899AR, MR9700AR, 264EXCHDE, MR3403AR, MR8229AR, MR2932AR, MR5239AR, MR3718AR, MR5150AR, MR7906AR, MR6855AR, MR8433AR, MR8920AR, MRR9946, MR9679AR, MR1936AR, MR2346AR, 4127SIGNA15, MR5043AR, MR8907AR, 3722SIG15T, MR7077AR, MR8570AR, MR2042AR, MR1437AR, MR1245AR, MR7856AR, MR2433AR, MR1720AR, MR5444AR, MR5790AR, 0910272080, 0910272089, 0910272087, 83151656091, 83193107602, 83147183761, 83207359389, 833MR000001, 83140192745A, 83215453018, 83151589682, 83200805122, 83164742085, 83212927900, 083027606532922, 083027609288917, 083027605498616, 083027608479920, 083027600426022, 083027606875420, 083027607691119, 083027604109319, 083027601632818, 083027600426222, 083027600874617, 083027606911319, 083027600486516, 083027606521417, 083027601703117, 083027607417021, MR52743961, 210110MR01, 083027608604518, MRRD0622, MR1726BO, MR7065BO, 2560124, BA4147MR01, MR51360451, MRR9040, MRR7716, 2849423, MRR10602, 1175978, MRRD0670, MRR9917, MRR8311, MRRD0764, MRR10597, MRR11632, MRR11499, MRRD0889, MRRD0859, MRR7919, MRRD1291, MRRD1157, MRRD0392, 2651970, MRR11526, MRRD1085, MRRD0909, MRR10914, 2705171, MRR11466, MRR11251, MRRD0632, MRRD0568, MRRD0436, MRR11576, MRR4548A, MRR11178, MRR10328, MRR10064, 1337081, 2839886, 74954, 2626380, 2761824, MRRD1232, 1347499, MRRD0634, MRR11488, MRR11621, MRR11456, MRRD0466, MRR10927, MRRD0412, MRR11001, 2599138, MRR11619, MRRD1004, MRRD0679, MRR11293, MRRD0437, 1192292, MRR11186, MRR11404, MRRD0673, MRRD0352, MRRD0314, MRRD1180, MRRD1159, MRR10160, MRRD0401, MRRD1400, MRRD0393, 1200823, 60357, MRRD1254, 34574, MRRD0538, 2707330, MRRD0927, MRR11566, MRR8015, MRRD0595, MRRD0470, MRR8517, 2682131, MRR11494, MRR11297, MRR11108, MRRD0924, MRR10744, MRR9306, MRRD0616, MRR11626, MRR11375, MRR1183, MRR11031, MRR11087, MRR10855, MRR1560SX2, MRRD1324, MR1543SX8, MRR11547, MRR10840, MRR11391, MRR10939, MRRD1002, MRRD1122, MRRD0813, MRR11657, MRRD0988, MRR11177, 33262, MRR9279, MRRD0579, MRR11646, MRR11618, MRR11636, MRR11579, MRR11577, MRR11562, MRR11536, MRR11088, MRR10899, MRR10997, MRR11000, 1292548, 2705318, 1202470, 2613126, 1167491, 1196362, 1200954, 1184373, MR1355680, MRR11187, MRR8992, 2807598, MRR11614, 2831309, MRR10084, MRR8562, MRRD0958, MRR11647, MRRD0865, MRRD1383, MRRD0877, MRR11630, MRR3140, MRR6664, MRR8267, MRRD1081, 2713328, MRR11610, MRR10845, 2728519, MRR11653, MRRD0419, 2776720, 2668464, MR255906MR0, 1238483, MRRD0905, MRRD1181, MRRD0914, MRR11372, MRRD1020, MRR10964, MRR10813, MRYR2150, MRR10826, MRRD0952, MRRD1050, MRR8789, MRR11471, 2742381, MRR9929, 2713415, MRR8057A, MRR10274, 1344119, MRR11223, MRR11081, 2535122, MRR11038, MRR8310, 2708848, MRRD1037, 4737487MR11, MRR11640, MRR11555, MRR11382, MRR11358, MRR11188, MRR10995, MRR8405, MRR8460, 2831204, 26290-1, 2730904, 1202525, 1202522, 1202515, MRR8605, 2626827, MRRD0480, 47924-1, MRRD0828, MRRD0411, BR93131XXX, BG4600MR01, BG4612MR01, MR51201071, MR52096141, 250782MR, MRR6466, MRR1120, MRR8034, MRR1946, CUCMR1, MR4038CL, MRRD0718, MR2527CL, MRR8837, MRR2854, MRR10957, MR1914CL, MRRD0680, MRR4116, MRR1134, MR5061CL, MEDSMR1, MRR8531, MRRD0997, MR9406CL, MR8714CL, HBLUCOMR01, MRR5840, MR7894CL, MRR2425, 082427040285, 082427040212, 082427040225, 082427040216, 082427040203, 082427220123, 082427220082, 082427220064, 082427130173, 082427130093, 082427100312, 082427060090, 082427270068, 082427160302, 082427160292, 082427040223, 082427040237, 082427040231, 082427230156, 082427090448, 082427090400, 082427200216, 082427010155, 082427090373, 082427090380, 082427100288, 082427090337, 082427160241, 082427090323, 082427190147, 082427160375, 082427230154, 082427120225, 082427080107, 082427080078, 082427250080, 082427140145, 082427030173, 082427030163, 082427160227, 082427090362, 082427090358, 082427100296, 082427070233, 082427070182, 082427250082, 082427140186, 082427280019, 082427090384, 082427240095, 082427220077, 082427220071, 082427030180, 082427190150, 082427100407, 082427090403, 082427290030, 082427160235, 082427160319, 082427160310, 082427160318, 082427160256, 082427160362, 082427160238, 082427240074, 082427070215, 082427010134, 082427010129, 082427090401, 082427090334, 082427090305, 082427090328, 082427090434, 082427090419, 082427090436, 082427090321, 082427090393, 082427090325, 082427090303, 082427090295, 082427210191, 082427210198, 082427190139, 082427120214, 082427120290, 082427110140, 082427200151, 082427200238, 082427200201, 082427020097, 082427020111, 082427060119, 082427060095, 082427190143, 082427160242, 082427100347, 082427100305, 082427100396, 082427100307, 082427100294, 082427100338, 082427130117, 082427080071, 082427310174, 082427230148, 082427230262, 082427230253, 082427230245, 082427270071, 082427270076, 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MRRD1283, MRHM0503, 2904666HDI, 5338MR15T, 1084MREINP, 570844TWINSPEED, MRRD1416, MRRD1389, 2673175LXMR, 57MRHD1178, MRRD0950, 2951520HDE, MRG2LS16226, MRRD1242, MRRD1453, MRRD1437, MRRD1449, MRRD1447, MRRD1213, 48MRE2744667, MRR8808, MRRD1233, MRG2YS13039, MRRD1370, MR292391MR0, MRR4342, MRR10970A, MRRD1287, MRRD1436, MRRD1411, MRRD1357, MRR2714, MRRD1076B, 31MRE2540752, MRRD1321, 2832672HDE, MRRD1410, MRRD1407, MRRD1380, MRRD1347, MRR8394, MRRD0536, MRR294, 2912069MRHDE, 2867718MRHDEAW, 2867718MRHDE, MRRD1335, MRRD1332, MRRD1279, MRR11558, MRR9546, 2856565HDE, MRR8240, MR287078MR0, 99201MR15, MRR0455, MR52353941, MR49554941, MR52293331, MR48582681, MA1488MR01, MR47289841, MA1151MR01, MR52300401, MR52299021, MR50497271, MR52293461, MR52298391, MA1955MR01, MA1955MR02, MA1588MR01, MA1087MR01, MA1737MR01, MA1252MR02, MA1278MR01, MA1233MR01, MA1650MR01, MA1152MR02, MA1465MR01, MA1502MR01, MA1047MR01, MA1727MR01, MA1083MR01, MR52293211, MA1479MR01, MA1460MR02, MA1881MR01, MA1339MR01, MR47780703, MA1296MR01, MA1864MR01, MR52298831, MA1938MR01, MA1263MR01, MA1219MR01, MA1769MR01, MA1020MR02, MA1711MR01, MR50554841, MA1818MR01, MA1197MR01, MA1003MR01, MA1941MR01, MZ1001MR01, 6073MR0017, 6073MR0040, 1573MR0004, 6073MR0016, 6073MR0024, 1573MR0005, 083027002514618, 083027003210019, ECT0220, RTD0123, NG1982MR01, NG1739MR01, NG1915MR01, NG1432MR01, NG1410MR01, NG1743MR02, NG1265MR01, 9447742, NG1359MR01, NG1356MR01, NG1043MR02, NG1256MR01, NO1021MR02, NO1284MR01, MR51714511, OM1139MR01, OM1121MR01, OM1020MR01, PK1373MR01, PK1314MR01, PK1248MR01, PK1623MR01, PK1300MR03, PK1300MR02, PK1242MR01, PK1628MR01, PK1453MR01, PK1391MR01, PK1629MR01, PK1627MR01, PK1390MR01, 2850446, MRR9466, MRRD0691, MRR10989, MRR9894, MRR8090, 38210315MRI, 2700602SIGNA, MR4122PE, MR5610PE, 1557MR0050, 1557MR0059, 1557MR0022, 1557MR0033, 1557MR0052, 1557MR0045, 1557MR0051, 1557MR0020, 1557MR0030, 1557MR0012, 1557MR0041, 1557MR0061, 0843270007, 1557MR0013, PL1797MR03, P00652MR01, P00666MR01, PL0677MR01, PL0620MR02, P00665MR01, PL2256MR03, PL2256MR01, PL1493MR01, P00020MR01, PL1754MR01, PL1745MR01, P00612MR01, PL1724MR01, PL3927MR01, PL1760MR01, PL0659MR01, P00360MR01, PL1772MR01, PL0439MR02, PL1016MR01, PL1709MR02, PL1720MR01, P00304MR01, P00224MR02, P00224MR01, PL0675MR04, P00027MR01, PL1813MR01, P00644MR01, P00403MR01, PL3547MR01, PL1501MR04, PL3596MR01, 600118MR02, PL2342MR01, PL3594MR01, PL1776MR01, PL1107MR02, PL0631MR01, PL1790MR01, PL1787MR01, P00477MR01, PL3889MR01, P00329MR01, PL1316MR01, PL2773MR02, PL3362MR01, PL1755MR01, PL0869MR01, P00529MR01, PL1060MR01, PL1730MR03, PL1355MR01, PL2309MR01, PL0001MR01, PPS75601, PPS54202, PPS26404, PPR02110, PER18426, PPR10411, PPR29115, PPR104800, PPS80401, PER01511, PPR59000, PPR62007, PPR94108, PPS49012, PPR92403, PPR23104, PER08728, PPS18202, PPS21302, PPR96413, PPR58104, PPS62102, 809269EXCITE, 787840EXCITE, 787263HDX, QA1095MR01, RO1138MR01, RO1430MR01, RO1232MR01, RO1494MR01, RO1016MR01, RO1463MR01, RO1462MR01, RO1345MR01, RO1321MR01, RO1149MR01, RO1080MR01, RO1150MR01, RO1200MR02, RO1200MR01, RO1227MR01, RO1198MR01, MR50839571, RO1329MR01, RO1572MR01, RO1172MR01, RO1678MR01, RO1098MR04, RO1428MR01, RO1038MR01, RO1646MR01, RO1210MR01, RO1015MR02, RO1102MR03, RO1595MR01, RO1584MR01, RO1355MR01, RO1090MR02, RO1664MR01, RO1255MR01, RO1640MR01, RO1356MR01, RO1438MR01, RO1358MR01, RO1473MR01, RO1122MR01, RO1602MR01, RO1146MR01, RO1429MR01, RO1325MR01, RO1160MR01, RO1622MR01, RO1362MR01, RO1363MR01, RO1453MR01, RO1231MR02, RO1272MR01, RO1364MR01, RO4172MR02, RO1303MR01, RO1471MR01, RO1466MR01, RO1365MR01, RO1205MR01, RO1092MR01, RO1128MR02, RO1598MR01, RO1673MR01, RO1051MR01, RO1087MR02, RO1465MR01, RO1257MR01, RO1252MR01, RO1644MR01, RO1674MR01, RO1487MR01, RO1308MR02, RO1593MR01, RO1229MR01, RO1159MR01, RO1059MR02, RO1431MR01, RO1060MR02, RO1562MR02, RO1460MR01, RO1336MR01, RO1508MR01, RO1371MR01, RO1042MR01, RO1373MR01, RO1125MR01, RO1152MR01, RO1194MR01, RO1675MR01, RO1550MR01, RO1374MR01, RO1577MR01, RO1544MR01, RO1412MR01, RO1416MR01, RO1144MR01, RO1432MR01, RO1184MR01, RO1455MR01, RO1133MR01, RO1153MR01, RO1447MR01, RO1139MR01, RF0129MR01, RU0076MR02, RF2748MR01, RF2631MR01, RF1815MR01, RU7536MR01, RF0367MR01, RF3042MR01, RU1078MR01, RU6340MR04, RF0567MR01, RU3923MR01, RU0473MR01, RU3889MR01, RF2072MR02, RU7618MR01, RU3926MR01, RF3270MR01, RU2580MR03, RU3611MR01, RU2652MR03, RF0001MR01, RU7524MR01, RU3408MR01, RU7550MR01, RF3564MR01, RU3447MR01, RF1647MR01, RU2157MR01, RU1115MR01, RF0252MR01, RF2584MR01, RF1352MR01, RF1332MR01, RU1198MR01, RU3623MR01, RU1086MR01, RF1695MR01, RU4440MR01, RF1258MR01, RF3584MR01, RF3081MR01, RF3082MR01, RF3317MR01, RU3867MR01, RU3261MR01, RU3291MR01, RU7872MR01, RU7180MR01, RF0852MR01, RU3462MR01, RU7545MR02, RU2447MR01, RU5552MR01, RU8891MR01, RU7564MR01, RF0484MR02, RU1017MR02, RU1017MR03, RU8916MR01, RF2406MR01, 600100MR04, RF1911MR01, RU4454MR01, RU1204MR04, RU1653MR02, RU3929MR01, RU3919MR01, RF1749MR01, RU0402MR01, RU2144MR01, RF3314MR01, RU7884MR01, RF3434MR01, RF2871MR01, RF1283MR01, RU7468MR01, RU6177MR01, RU3911MR01, SA2330MR01, SA2653MR01, SA2214MR01, SA2161MR01, SA2485MR01, SA2191MR01, SA1012MR05, SA1012MR04, SA1056MR01, MR53659451, MR53659481, MR53659491, MR53659501, RS4001MR01, RS4124MR01, RS4019MR01, RS4012MR01, RS4156MR02, RS4052MR01, RS4032MR02, RS4043MR01, 6073MR0012, 6073MR0009, 0847270018, 0847270029, SGMRIDUMMY123, 6073MR0026, 6073MR0025, 6073MR0022, 0847270001, SK1043MR01, ZA2103MR03, ZA1918MR03, ZA2224MR02, ZA1017MR01, ZA1038MR02, ZA1000MR04, 6225296, ZA3049MR01, ZA2015MR03, ZA1560MR01, ZA2372MR02, ZA2222MR02, 8282959, ZA2250MR01, ZA2119MR02, 09865187, ZA2101MR02, ZA1442MR02, ZA3192MR02, ZA3293MR01, ZA1058MR02, 09632508, ZA2100MR01, ZA1071MR02, ZA1006MR03, YP170A26, DPD59704, MPX43106, MPX35202, MP750816, MP825711, MP118827, ME208331, CE137808, NPV58123, FPG97802, DPN34709, FPD27500, NE209912, NPV63900, MPX98004, DEL26400, CP749713, MPX43803, FEC800352, DE641215, FE387840, FPD40200, DPD23001, DEL71943, MP385511, YE600109, DPN62302, DPA93505, DE492A30, MEX25550, FEG45915, NPV57900, NPV07308, YE167215, MP601318, FPG23603, DPN47008, ME051539, MEX71105, GPX25903, UE535A57, GPX22600, MP324987, MPX68102, DE669614, MEX71200, CPA91609, CEE15655, DPD37900, YP567303, NE741452, NE688850, CE671328, EE672844, FPG10102, FPG08204, MPD20500, DPN88433, MP3249117, NP083636, NP083635, 083027802635819, 083027800190520, 083027808117324, 083027800189520, SD1084MR01, MR52587891, MR52588111, MR51941681, MR50445311, SD1088MR01, SD1080MR01, SD1081MR01, SD1057MR01, MR51941821, SD1094MR01, SZ0002MR01, BD017MR01, O011MR02, O011MR01, N006MR01, K001MR01, K002MR01, Z001MR02, A013MR02, C018MR01, 824158MR01, 680542MR01, 501030MR02, 115030MR01, 167429MR01, 167682MR01, SY2074MR01, SY1012MR02, SY2077MR01, SY2078MR01, SY2013MR02, 0853270161, 0853270181, 0853270216, 0853270224, MR50718431, 1573MR0023, 1573MR0054, 1573MR0022, 1573MR0026, 0856270043, 1573MR0017, 1573MR0064, 1573MR0007, 0856270045, 0856270042, 0856270054, 1573MR0011, 0856270055, TN1588MR01, TN2004MR01, TN2004AW02, TN2002MR01, TN1278MR01, TN1632MR01, TN2005MR01, TN1699MR01, TN1018MR02, FSSADUMMMR01, TNDUMMMR01, TN1366MR01, 21028MRS01, 34717MRS01, 34717MRS02, 01071MRS01, 01062MRS01, 01005MRS02, 02008MRS01, 04011MRS01, 06236MRS01, 06211MRS01, 06184MRS07, 06184MRS02, 06184MRS03, 06185MRS01, 34787MRS01, 06172MRS01, 06167MRS01, 06072MRS01, 07023MRS02, 07023MRS01, 07040MRS01, 07039MRS01, 09019MRS01, 09018MRS01, 10022MRS01, 10021MRS01, 14008MRS01, 9435702, 16052MRS01, 16055MRS01, 16053MRS01, 16018MRS03, 16003MRS01, 17014MRS01, 20001MRS02, 25018MRS01, 25018MRS02, 25008MRS01, 26024MRS01, 26022MRS01, 31041MRS01, 31031MRS01, 31030MRS01, 31039MRS01, 34241MRS01, 54003MRS01, 34722MRS01, 34716MRS02, 34716MRS01, 34062MRS01, 34472MRS01, 34478MRS01, 34389MRS02, 34386MRS02, 34453MRS01, 34450MRS01, 34459MRS01, 34756MRS02, 34433MRS01, 34419MRS01, 34416MRS01, 35118MRS01, 35092MRS01, 35072MRS01, 35045MRS01, 46014MRS02, 46032MRS01, 37006MRS01, 38022MRS01, 79004MRS02, 71010MRS01, 71009MRS01, 71007MRS01, 40009MRS01, 41044MRS01, 34239MRS02, 41031MRS01, 43023MRS01, 43022MRS01, 00023MRS03, 44017MRS01, 45019MRS02, 45023MRS01, 45021MRS01, 45022MRS01, 47011MRS02, 33044MRS02, 33045MRS01, 49005MRS02, 52013MRS01, 53012MRS01, 55018MRS01, 55025MRS01, 55029MRS01, 55032MRS01, 63028MRS01, 60012MRS01, 31027MRS02, 61022MRS01, 61018MRS01, 65017MRS03, 65017MRS02, 66008MRS01, 67019MRS01, 68012MRS01, 06051MRS01, 10020MRS01, 10016MRS01, 19013MRS01, 20017MRS01, 21020MRS01, 28005MRS02, 8495586, 34308MRS01, 06182MRS01, 34455MRS01, 55038MRS01, 60001MRS01, MR49966381, UK1006MR01, MR51420931, UA4810MR01, MR53527441, UA4410MR01, MR53497281, AE1715MR01, AE1160MR01, 10718MRS01, 70001MRM01, 00055MRS03, 10740MRM01, IE1261MR01, 00298MRS01, IE1590MR01, 70383MRS03, 70383MRS04, 00136MRS02, 10893MRM01, 11670MRS01, 00577MRS02, 10498MRS01, 10724MRS01, 00824MRS01, 00313MRS03, 10695MRM04, 10079MRM83, 10719MRS01, 2647, MRRD1172, 2880725MR, MR48271631, UZ1359MR01, UZ1316MR01, UZ1357MR01, UZ1358MR01, MR52113731, UZ1352MR01, UZ1344MR01, UZ1360MR01, UZ1306MR01, 3882936037MRAND, 3882857623MRCTR, 3882647967MROCC, 38803561MRMET, 5973MR0010, 5973MR0066, 5973MR0049, 5973MR0043, 5973MR0035, 5973MR0073, 5973MR0045, 5973MR0039, 5973MR0041, 5973MR0029, 5973MR0020, 5973MR0036, 5973MR0019, 5973MR0098, 5973MR0062, 5973MR0034, ZW6019MR01

Distribution pattern

Worldwide distribution.

device · product 16 of 26

SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

Z-2474-2024
Recall number
Z-2474-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
206 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 082427220113, 082427220120, 082427220099, 082427310159, 082427220101, 82427140311, 082427140312, 082427100465, 082427110158, 082427140254, 082427070286, 082427110136, 082427040296, 082427040293, 082427180072, 082427150126, 082427150125, 082427140266, 082427140239, 082427090462, 082427130138, 082427140263, 082427090428, 82427090443, 082427310166, 082427070295, 082427230239, 082427140277, 082427140238, 082427140269, 082427210231, 082427160334, 082427100498, 82427140326, 082427140219, 082427140290, 082427140230, 082427120299, 082427100472, 082427110131, 082427070306, 082427140220, 082427230211, 82427070296, 082427070264, 082427220108, 082427140255, 082427190189, 82427130148, 082427110139, 082427110124, 82427210254, 082427150122, 082427290062, 082427290054, 082427160342, 082427180066, 082427070293, 082427070307, 082427070292, 082427070275, 082427070303, 082427070289, 082427070272, 082427070267, 082427070320, 082427070294, 082427070304, 082427090439, 082427090468, 82427090435, 082427090417, 82427210255, 082427130167, 082427120298, 082427120347, 082427130160, 082427020125, 082427020110, 082427110127, 82427100462, 82427100432, 082427100488, 082427100427, 082427100453, 082427100438, 082427130137, 082427130136, 082427310171, 082427040309, 082427230243, 082427230216, 82427230214, 082427230229, 082427230247, 082427230218, 82427270084, 82427140309, 082427140270, 082427140261, 082427140262, 082427140298, 082427140272, 082427140256, 082427140264, 082427140228, 82427140313, 082427140292, 082427140302, 082427140304, 082427130154, 082427130165, 082427130161, 082427130162, 082427130149, 82427130186, 082427130142, 082427130172, 082427130166, 082427130133, 082427040288, 82427040334, 82427040332, 082427020116, 082427130135, 082427230202, 082427230207, 082427130169, 082427230235, 082427230221, 082427230209, 082427230224, 082427230204, 082427230225, 082427230244, 082427110137, 082427110134, 082427100424, 082427100452, 082427100467, 082427100443, 082427100470, 082427100428, 82427100508, 082427100468, 082427160371, 82427130182, 82427180080, 082427180079, 082427180073, 082427180075, 082427270080, 082427270083, 082427130168, 082427120312, 82427130185, 082427130178, 082427130163, 082427120317, 082427120318, 082427120329, 082427120310, 082427070310, 082427070305, 082427070317, 082427070284, 082427070258, 082427070287, 082427070311, 082427070288, 082427070268, 082427070337, 82427090500, 082427090431, 082427140281, 082427140260, 082427140253, 082427140291, 082427140306, 082427140293, 082427140233, 82427130183, 082427140282, 082427140247, 082427140243, 082427140221, 082427140271, 082427140244, 082427140284, 082427140280, 082427140316, 082427140276, 082427140236, 082427140286, 082427140237, 082427210252, 082427130171, 082427210243, 082427210235, 82427210262, 082427130179, 082427290058, 082427150123, 082427150133, 082427220131, 82427220132

Distribution pattern

Worldwide distribution.

device · product 17 of 26

SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

Z-2475-2024
Recall number
Z-2475-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
308 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 082427110089, 082427110085, 082427040318, 082427010165, 082427030217, 082427160341, 082427190152, 082427110096, 82427100448, 082427290071, 082427160273, 082427090359, 082427230237, 082427130113, 082427130115, 082427130130, 082427160366, 082427030166, 82427210264, 082427070299, 082427040251, 082427120336, 082427200172, 082427010146, 082427040307, 082427010170, 082427010216, 082427090365, 082427270079, 082427010207, 082427010153, 082427030213, 082427030155, 082427310135, 082427110106, 082427160262, 082427070239, 082427310133, 082427070247, 082427230160, 082427210207, 082427160316, 82427230230, 082427200137, 82427200235, 082427160311, 082427120242, 082427200167, 082427140185, 082427160312, 082427160290, 082427250093, 082427160303, 082427100394, 82427170050, 082427170027, 082427170031, 082427100461, 082427110126, 082427110102, 082427190155, 082427090474, 082427100390, 082427120294, 082427150110, 082427160352, 082427160293, 082427070227, 082427210253, 082427310141, 082427240087, 82427120314, 082427120367, 82427070340, 082427220075, 082427220087, 082427140190, 082427060097, 082427090361, 082427290048, 082427290069, 082427290039, 082427160295, 082427160374, 082427160327, 082427160394, 82427160420, 082427160291, 82427160368, 082427160367, 082427160416, 082427160359, 082427160364, 082427180074, 82427180084, 082427240091, 82427240110, 082427240111, 082427170032, 082427170028, 082427070234, 082427070224, 082427070343, 082427070279, 082427070339, 082427070236, 82427070350, 082427070242, 082427070335, 082427070257, 082427010205, 082427010158, 82427010218, 082427010172, 082427010202, 82427090495, 082427210205, 082427210204, 082427190158, 082427190159, 082427190145, 82427190202, 082427190149, 82427190192, 082427190197, 082427190163, 082427120339, 082427120233, 082427120374, 082427120264, 082427120297, 082427120260, 082427200212, 082427200231, 082427200150, 082427200174, 082427200155, 82427200197, 082427200165, 82427020134, 082427020099, 082427020127, 082427020120, 082427020096, 082427030205, 082427030221, 082427030169, 82427060113, 082427060099, 082427230173, 082427010189, 082427100385, 082427100481, 082427100466, 082427100436, 082427100359, 082427100361, 082427100500, 082427100425, 082427310181, 082427310154, 082427310127, 082427310149, 082427310148, 082427230164, 82427230260, 82427230265, 082427230168, 082427230143, 082427230175, 082427230205, 082427230187, 082427270075, 082427270089, 082427250095, 082427140199, 082427250116, 082427250100, 082427250085, 082427250101, 082427060082, 82427060123, 082427040273, 082427040294, 082427040316, 82427040323, 82427040338, 082427020089, 82427020117, 082427020123, 082427020103, 082427230182, 082427230242, 082427230238, 082427230165, 82427110165, 082427110153, 082427110125, 082427110147, 082427110098, 82427100503, 082427100506, 082427100400, 082427100460, 082427080086, 082427080137, 082427080118, 082427080135, 082427080133, 082427080116, 082427080113, 082427080103, 82427160417, 082427160419, 082427160369, 082427160351, 082427160281, 082427160333, 082427160397, 82427160410, 82427160377, 082427160421, 082427160425, 082427160406, 082427270085, 082427120332, 082427120315, 082427120342, 82427120368, 082427120348, 082427120306, 082427120362, 82427200237, 082427200218, 082427200198, 82427200225, 82427200228, 082427200194, 082427200187, 082427200192, 082427200153, 082427210259, 082427070348, 082427070244, 082427070309, 082427070313, 082427070316, 82427070325, 82427070346, 082427070240, 082427070327, 082427070330, 082427070255, 082427070344, 082427070248, 082427070285, 082427070312, 082427090367, 082427090460, 82427090496, 82427090501, 082427140189, 082427140315, 082427140332, 082427210239, 082427210234, 82427210265, 082427190198, 082427190191, 082427190179, 082427220100, 082427290073, 082427290061, 082427290049, 082427260012, 082427240101, 082427240102, 082427240099, 082427240113, 082427240100, 082427240103, 082427240104, 082427030199, 082427030210, 082427030194, 82427030209, 082427030228, 082427030215, 82427030220, 082427030206, 082427030165, 082427030181, 082427220085, 082427220138, 82427220139, 082427310153, 082427040303, 082427310160, 082427010152, 82427010200, 82427010215, 82427010217, 082427010210, 082427010164, 082427010208, 082427010209, 082427010195, 082427010193

Distribution pattern

Worldwide distribution.

device · product 18 of 26

SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

Z-2476-2024
Recall number
Z-2476-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
81 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 082427110087, 082427230163, 082427160298, 082427070229, 082427100384, 082427100377, 082427120249, 082427080097, 082427130131, 082427100383, 082427100368, 082427160308, 082427120270, 082427120268, 082427150113, 082427150115, 082427010174, 082427120282, 082427120281, 082427120255, 082427120253, 082427090378, 82427120311, 082427200139, 082427250125, 082427140203, 082427210214, 082427140201, 082427090366, 082427150108, 082427160258, 082427120275, 082427190165, 082427220115, 082427220083, 082427300035, 082427210242, 082427130128, 082427030178, 082427110088, 82427160344, 082427190175, 082427130132, 082427120251, 082427120293, 082427120263, 082427120248, 082427120265, 082427200180, 082427200149, 082427020101, 082427030202, 082427060121, 082427140192, 082427100376, 082427230167, 082427230161, 082427250090, 082427140184, 082427100501, 082427100437, 082427160328, 82427120341, 082427120246, 082427120361, 082427120316, 082427200188, 082427200158, 082427070254, 082427070274, 082427140245, 082427170036, 082427210215, 082427190201, 082427150137, 082427240090, 082427310164, 082427010184, 082427010192, 082427010160, 082427010201

Distribution pattern

Worldwide distribution.

device · product 19 of 26

Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2477-2024
Recall number
Z-2477-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
375 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: MSF067-1-6AB94D05, DZ1570MR01, MRR9492, MRR10103, MRR10449, MRR9613, MRR9196, MRR9924, MRR9725, MRR10479, MRR9358, MRR9372MM3, MRR9496, 083027600051013, MRR8258, MRR10217, MRR8634, MRR9104, MRR10184, MRR9949, MRR8550, MRR9286, MRR9231, MRR9153, MRR8685, MRR10207, MRR8755, MRR9962, MRR8669, MRR8972, MRR9920, MRR10124, MRR10693, MRR10081, MRR9131, MRR8647, MRR9484, MRR8609, MRR10162, MR1714SX5, MRR8984, MRR8602, MRR10063, MRR9968, MRR9037, MRR9980, MRR9811, MRR10213, MRR10237, BG4608MR01, MRR9350, MRR9031, 082427110037, 082427110039, 082427220030, 082427220032, 082427220029, 082427220028, 082427190073, 082427210085, 082427150052, 082427150046, 082427030077, 082427160108, 082427170015, 082427170018, 082427040126, 082427200069, 082427010062, 082427010058, 082427210126, 082427200055, 082427290012, 082427160099, 082427230062, 082427090205, 082427270043, 082427310049, 082427160125, 082427160120, 082427090185, 082427110057, 082427160096, 082427230076, 082427100157, 082427150054, 082427150055, 082427160109, 082427180025, 082427180026, 082427240033, 082427240027, 082427240032, 082427210086, 082427070092, 082427070077, 082427090158, 082427090199, 082427090154, 082427090216, 082427090156, 082427090191, 082427090167, 082427090172, 082427090152, 082427090197, 082427090177, 082427090243, 082427210067, 082427210088, 082427210095, 082427190063, 082427190056, 082427190054, 082427190052, 082427190062, 082427190060, 082427190059, 082427190057, 082427190058, 082427200059, 082427200054, 082427200051, 082427200061, 082427200085, 082427200079, 082427200067, 082427200070, 082427020048, 082427020043, 082427020046, 082427030068, 082427200096, 082427090155, 082427100167, 082427100163, 082427100155, 082427100162, 082427310067, 082427230072, 082427230071, 082427230054, 082427230066, 082427230060, 082427270035, 082427060037, 082427020040, 082427230070, 082427110038, 082427100151, 082427120127, 082427200060, 082427200044, 082427200063, 082427200064, 082427070076, 082427070091, 082427090184, 082427090183, 082427090186, 082427170017, 082427210103, 082427210079, 082427210092, 082427190051, 082427190068, 082427150049, 082427240040, 082427220025, 082427310055, 082427310051, 082427010059, MRR8316, MRR10123, MRR9787, MRR8587, MRR8724, MRR9448, MRR8333, MRR9530, 2943672BRIVO, MRR8727, MRR9190, MRR8270, 805609MR01, GH5014MR01, MR5407GT, MRR8813, 083027600033412, 083027280005313, 083027280035313, 083027000002713, 083027240003113, 083027240009512, 083027240046912, 083027100004713, 083027100020013, 083027820034810, 083027860004512, 083027861104811, 083027868443311, 083027860028112, 083027200051414, 083027200494913, 083027208469611, 083027206189511, 083027201003119, 083027200037012, 083027207329111, 083027200044913, 083027205952123, 083027060039211, 083027044291311, 083027800002313, 083027800405712, 083027805544513, 083027849928710, 083027601012912, 083027607456310, 0835270033, 0835270043, 0835270030, 0835270023, 0835270047, A5163111, A364241704, MR332876HM2, MRR8312, PC5014, PC5022, PC5059, PC5079, PC5010, PC5017, PC5047, PC5073, PC5035, PC5045, PC5056, PC5060, PC5151, PC5072, PC5100, PC5033, PC5069, PC5001, PC5140, PC5015, PC5008, PC5023, PC5038, PC5025, PC5071, PC5046, PC5021, PC5150, PC5052, PC5039, PC5007, PC5051, PC5078, PC5049, PC5064, PC5057, PC5019, PC5044, PC5016, PC5076, PC5066, PC5036, PC5031, PC5011, PC5048, PC5018, PC5043, PC5054, PC5055, PC5003, PC5050, PC5040, PC5090, PC5067, PC5024, PC5063, PC5013, PC5026, PC5053, PC5068, PC5028, PC5061, PC5030, PC5037, PC5027, PC5006, PC5042, 0850270356, 0850270349, 0850270429, 0850270378, 0850270364, 0850270383, 0850270352, LV4058MR01, MRR8614, MA1085MR01, MA1421MR01, MA1014MR02, NG1065MR01, NG1127MR01, NG1097MR01, PL2893MR01, PL2997MR01, PL1809MR01, PL2717MR01, RO1221MR01, RU7464MR01, RU3028MR01, RU5248MR01, RU6147MR01, RU1203MR01, RU1778MR01, RU7816MR01, RU3240MR01, RU7539MR01, RU2652MR02, RU3908MR01, RU8225MR01, RU1997MR01, RU3759MR01, RU2607MR01, RU2272MR01, RU7426MR01, RU8300MR01, RU6261MR01, RU3609MR01, RU7865MR01, RU8407MR01, RU7312MR01, RU4306MR01, RU3794MR01, RU7827MR01, RU3469MR01, RU3776MR01, RU3951MR01, RU8151MR01, RF2883MR01, A5940817, ZA2315MR01, ZA2471MR01, UPW01801, PPS68403, MPD34400, NPD03800, 0856270060, 0856270059, 0856270058, 0856270056, 0856270057, 0856270051, 0856270069, 06138MRS01, 09015MRS01, 13007MRS01, 34340MRS01, 34334MRS01, 46014PRO06, 46014MRS01, 46016MRS01, 55021MRS01, 07027MRS01, 48005MRS01, UZ1020MR01, 0859270016, 0859270017, 0859270018,

Distribution pattern

Worldwide distribution.

device · product 20 of 26

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2478-2024
Recall number
Z-2478-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
469 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 1009000, 201871MR, DZ1396MR01, DZ1820MR01, DZ1339MR02, DZ1339MR01, DZ1061MR01, DZ1406MR01, DZ1285MR01, DZ1191MR01, 0910272060, 0910274038, 0910274036, BH1038MR01, MRR9112, MRR10326, MRR8777, MRR10248, MRR9308, MRR10649, MRR10657, MRR10586, MRR10646, MRR10703, MRR10694, MRR10648, MRR10676, MRR8247, MRR10417, MRR10842, MRR10620, MRR10145, MRR9922, MRR9979, MRR10393, MRR9829, MRR8339, MRR11105, MRR10416, MRR10514, MRR10812, MRR9091, MRR10742, MRR8318, MRR10418, MRR9927, MRR8632, MRR8679, MRR8213, MRR9379, MRR10692, MRR10259, MRR10205, MRR10330, MRR11034, MRR9826A, MRR10690, MRR9033, MRR10478, MRR10529, MRR8249, MRR9080, MRR8969, MRR10201, MRR8714, MRR10793, MRR10013A, MRR8427, MRR11089, MRR10594, MRR9435, MRR10177, MRR10629, MRR10366, MRR10640, MRR10596, MRR9988, MRR10158, MRR10486, MRR9587, MRR10341, MRR10388, MRR10147, MRR10206, MRR9797, MRR9636A, MRR9450, MRR9947, MRR9271, MRR10227, MRR10062, MRR9000, MR1551SX1, MRR10336, MRR10115, MRR9877, MRR10726, MR1578SX4, MR1462SX1, MRR9318, MRR10645, MRR10218, MRR10076, MRR8392, MRR8861, MRR8835, MRR8194, MRR10584, MR1532SX1, MRR8424, MRR10442, MRR10885, MRR8415, MRR10603, MRR10606, MRR10619, MR1179SX1, MRR10656, MRR9500, MRR10680, MRR10143, MRR10082, MRR10065, MRR9544, MRR8831, MRR11307, MRR10642, MRR9043, 082427040158, 082427040159, 082427040131, 082427040134, 082427040136, 082427040138, 082427220034, 082427040156, 082427120128, 082427200082, 082427010067, 082427240051, 082427270031, 082427160112, 082427090225, 082427040130, 082427120140, 082427120139, 082427120123, 082427060036, 082427010068, 082427070165, 082427050035, 082427100179, 082427210089, 082427140118, 082427240036, 082427120111, 082427060054, 082427160119, 082427160093, 082427100209, 082427210112, 082427230086, 082427120105, 082427250035, 082427100205, 082427030083, 082427100197, 082427160102, 082427020051, 082427120108, 082427060045, 082427070085, 082427090182, 082427060041, 082427120115, 082427190055, 082427080035, 082427270038, 082427130070, 082427090222, 082427090203, 082427160116, 082427160115, 082427160111, 082427160092, 082427160121, 082427240029, 082427240026, 082427070121, 082427070088, 082427070106, 082427070093, 082427210122, 082427070105, 082427070124, 082427070118, 082427090239, 082427090210, 082427090219, 082427090236, 082427090209, 082427090207, 082427210117, 082427210140, 082427210100, 082427210104, 082427190061, 082427120094, 082427030087, 082427030085, 082427060047, 082427060053, 082427300016, 082427060044, 082427060050, 082427310106, 082427090213, 082427190094, 082427100190, 082427130068, 082427100177, 082427100193, 082427100212, 082427100222, 082427100178, 082427100174, 082427100206, 082427100196, 082427100195, 082427100180, 082427100188, 082427080039, 082427310088, 082427310043, 082427270047, 082427270041, 082427140095, 082427250043, 082427060043, 082427060039, 082427300017, 082427100152, 082427100203, 082427100186, 082427100171, 082427080045, 082427180024, 082427270036, 082427120096, 082427120119, 082427120109, 082427200057, 082427070084, 082427070082, 082427070099, 082427070080, 082427070086, 082427090217, 082427140092, 082427190074, 082427030075, 082427030072, 082427030091, 082427310052, MRR8406, EG1925MR01, EG3053MR01, EG1840MR02, EE4024MR01, 782057MR01, PC2287MR01, PC0395MR02, 805466MR03, 363893MR01, PC4529MR01, 782692MR01, HC7831MR01, 734128MR01, 164236MR02, H4678MR04, MRR8465, MRR8457, 083027105723017, 083027820014211, 083027288790310, 083027201106511, 083027842022620, 083027801024814, 083027808008011, 083027849290410, 083027000013013, 083027600004313, 0835270028, 0835270027, IQ1309MR01, A5714101, A106327806, PC0098, PC0089, PC0107, PC0075, PC0078, PC0048, PC0047, PC0049, PC0071, PC0050, PC0090, PC0115, PC0117, PC0085, PC0096, PC0057, PC0083, PC0087, PC0067, PC0082, PC0046, PC0052, PC0105, PC0110, PC0091, PC0068, PC0133, PC0130, PC0088, PC0122, PC0076, PC0101, PC0084, PC0074, PC0053, PC0086, PC0064, PC0042, PC0032, PC0111, PC0054, PC0103, PC0094, PC5005, PC0061, PC0065, PC0069, PC6102, PC0079, PC0041, PC0120, PC0077, PC0106, PC0066, PC0063, PC0039, PC0036, PC0097, PC0044, PC0051, PC0062, PC0109, PC0123, PC0102, PC0043, PC0035, PC0095, JO1147MR01, 0850270360, 0850270375, 0850270405, 0850270397, 0850270366, 0850270387, 0850270382, 0850270373, 0850270368, LV4012MR02, LV4031MR01, LB1359MR01, LB1088MR02, LB1358MR01, LB1364MR01, LT4026MR01, LT4043MR01, 2836414HDE, MRR8505, MA1134MR01, MA1487MR01, MA1471MR01, NG1126MR01, NO1200MR01, 0843270022, PL1620MR01, PL2059MR01, PL1798MR01, P00571MR01, PL2433MR01, PL1321MR01, PL2435MR01, PL2854MR01, P00607MR01, PL1951MR01, PPR44921, PPS07404, RO1105MR01, RO1223MR01, RF1709MR01, RF2036MR01, RU7690MR01, RU4356MR01, RU1130MR01, RU8412MR01, RU1346MR01, RU1136MR01, RU1875MR01, 600100MR03, RU1146MR01, RU3883MR01, RU1820MR02, SA2305MR01, SA2352MR01, SA2191MR04, SA2253MR01, SA1056MR03, ZA2198MR01, ZA2383MR01, MPX82245, UP925712, NPV86500, EPP04112, DPN95902, DPL32939, MPD24000, GPQ13902, NPV82605, UPW07802, MPX09800, FPG08503, MP720818, MPX75606, DPN79400, MPD19500, DPN62603, EPP11100, SY2060MR01, SY2058MR01, 0853270123, 0853270131, 0853270134, 0853270139, 0853270126, 0856270052, 0856270049, TN1033MR02, TN1241MR01, TN1008MR01, TN1530MR01, 16048MRS01, 16049MRS02, 34337MRS01, 42021MRS01, 68008MRS01, 34346MRS01, AE1373MR01, UZ1337MR01, 3882941838MRCTR, 3882928195MRMET, 0859270015, 0859270014, 0859270009, 0859270008

Distribution pattern

Worldwide distribution.

device · product 21 of 26

SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2479-2024
Recall number
Z-2479-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
72 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 662335PRIME, DZ2423MR01, DZ4388MR01, DZ3836MR01, MR6345AR, MR8657AR, MR1612AR, MR3084AR, MR7154AR, MRPM0464, MR51928141, 8.30276E+13, 8.30276E+13, MRPM1206, MRPM0798, MRPM0933, MRPM1282, MRPM0601, MRPM0960, MRPM0944, MRPM0725, MRPM1207, MRPM1287, MRPM1247, MRPM1226, MRPM1250, MRPM1175, MRPM1036, MRPM0658, MRPM0726, MRPM1309, MRPM0762, MRPM0420, MRPM0673, 082427290074, MR2427CO, MR8526CO, MRPM1310, MRPM1149, MRPM1298, MRPM1297, MRPM0841, MRPM1192, MRPM1268, MRPM0936, MRPM0547, EG1070MR02, MRPM1286, MRPM1201, 8.30278E+13, 8.30279E+13, 083027808226922, 7982MR0077, 7982MR0090, MR52529514, MR52529501, MR53615221, MR51674971, 8554396, NG1233MR01, MR51557681, NG1950MR01, MR5239828, 1557MR0056, 1557MR0058, MRPM0888, 8109195, 8154038, 9082439, 8033622, 9830MR0115, 1557MR0065.

Distribution pattern

Worldwide distribution.

device · product 22 of 26

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2480-2024
Recall number
Z-2480-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: GON5374156, DZ4952MR01, MRPM1180, MRR8022, MRPM0474A, MRPM1267, MRR8322, MRPM0795, MRPM1093, FI1271MR01, XM9192701, MR53305381, 397480MR01, PC7479MR04, H6383MR02, MR00226, MR00207, 1553MR0071, PPS79502, SA2215MR01, GON5419122, GON5435507, 9761071

Distribution pattern

Worldwide distribution.

device · product 23 of 26

SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only

Z-2481-2024
Recall number
Z-2481-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 650723PSYMR, 919684BIAC6, 919684MR5, 403944MR1, 082427040271, 082427040289

Distribution pattern

Worldwide distribution.

device · product 24 of 26

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

Z-2482-2024
Recall number
Z-2482-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: EX0001

Distribution pattern

Worldwide distribution.

device · product 25 of 26

SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System

Z-2483-2024
Recall number
Z-2483-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 319335MR1, A204479601, MR00026

Distribution pattern

Worldwide distribution.

device · product 26 of 26

SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use only

Z-2484-2024
Recall number
Z-2484-2024
Initiated
June 14, 2024
Classification
Class II
Status
Ongoing
Recalling firm
GE Medical Systems, LLC
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.

Code information

System ID: 608BUCKYS3T

Distribution pattern

Worldwide distribution.