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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81339

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

Open FDA event record

Event summary

Timeline bucket
September 14, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
GE Healthcare, 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

3 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 3

GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System

Z-0369-2019
Recall number
Z-0369-2019
Initiated
September 14, 2018
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
276

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A detector can detach and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A detector can detach and fall.

Code information

System ID #: 0002910670AX, 0890013983, 0890079382, 0890079382, 201461MYO, 201858MYO, 202464MYO, 202741MYO, 203483MILL, 203688MYO, 203797NM13, 205739MC, 207641MYO, 209524MS, 209944MS, 212420MS, 212420MS1, 212535MS, 212777MS, 212870MS, 215624MYO, 215676MYO, 215707MYO1, 228523VAMS, 229386MYOS, 248937MYO, 252331MC2, 256341NRM2, 256549MYOS, 270465MYO, 270886MG, 276964MYO, 281313MYO1, 281477NM1, 301884MG, 301905MYO, 302322MG, 302733MYO, 303341MYO, 304256MYO, 304263MYO, 305446MC, 305512MC, 305538MC, 305666MC, 316261KCMC, 316858GMC9, 318574NM, 318728MG1, 318812MG2, 318927NM, 325574MG, 334793MYO1, 334793MYO2, 334821ACN, 337491MYO, 352333MG2, 352564MG, 401729MYO, 401829MYO, 402315MC, 402NHIMC, 405359EMY, 408795MY1, 414219MYO, 414ISCGACQ3, 416231MG2, 416465MYO, 416465XEL1, 416763MG, 417847MG, 423648MYO, 423778MG1, 435734MG, 440326MC3, 443481MYO, 478453NM, 478929MCV, 480279NM1, 480288MG, 480425NM2, 480505NM1, 480835NM1, 501202SMG, 501278MYO, 502226MG1, 02587MYO, 502893N5, 503535MGA, 504329MG, 505462MYO, 505662MYO, 505887NUC2, 508626MG, 508674MG, 508778MYO, 508828MYO, 508992GENIE, 509684MG, 509946KICACQ, 513585MYO, 515358WLMG, 516488MS1, 516520MG, 516599MS, 516627MS, 516775MS, 516789MS1, 516798ELCINT, 516798MS, 519428MYO, 530582MG1, 530674MCV, 541667MG, 561332MG, 561627MC, 570823MC1, 570969MYO, 573334MG1, 580250MG1, 585341MC1, 585442MYO, 585UCVAMC1, 586775MG, 601553MG, 601553MYO, 601982MYO1, 601982MYO2, 602239NM2, 602239NM3, 602978NM2, 605977MS, 605977MYO, 606330MYO, 607432FMC, 608348MG, 610776MG1, 610778MYO2, 614293MYO2, 614464MYO1, 614865MYO1, 615222STNM1, 615329MSN1, 615342CNM, 615342FCNM1, 615449MCV, 615791MSNM1, 615851STH1, 615868MSNM1, 619668MYOSIGHT, 623298NM1, 623815MYO1, 623936NM1, 626308MG, 631447MYOSIGHT, 650617MS, 650991MY1, 661321MYO, 705434MYO, 706722MC, 706733MYO, 713456NM1, 713779NM1, 713917MYO1, 713943HPNM1, 714870MYO, 716488MYO, 716674MYO, 716878MGNUC, 717217MYO, 717344MYO1, 717344MYO2, 718265MS, 718268MS, 718317MS, 718442MS, 718584MS, 718670MS, 718777MS, 718780MS, 718830MS, 718837MS, 718998MS, 724752MYO, 731635MG, 732249MG1, 732281MYO, 732287MYO, 732431MYO, 732660MYO, 732888MYO, 732923MC, 740653MYO1, 760957MG1, 770638MY, 770732MY, 781979MYO, 802524MG, 803256MY02, 803256MY03, 803771MY01, 812949MYO, 813353MYO, 813615MYO, 815759MYO, 816276BMYO, 817250MYO, 817481MS, 817543MG, 818243MC1, 818734MYO, 828586MYO, 843761MC, 847360MYO, 847444MYO, 850696WMG, 850912VAMY, 856374MYO, 856589MCV, 860350MILL, 863687MYO, 864455MYO, 864716MYO, 865984MYS, 870338MG, 870524MYO, 890013983, 890534MC, 904202MYO1, 904202MYO2, 907677NUCACQ, 908273MYO, 908587MYO, 913541OPM, 913684CMG, 914235MS, 914968MYO, 918307MY1, 919684MYST1, 920531MG, 928314NM1, 928505NM1, 928505NM2, 936266SLNM2, 940320MYO, 941412MYO, 941412MYO2, 941792MYO, 949770MYO, 954382MC1, 972475MYO, 972494MYO, 972562MY01, 972562MY02, 973267MYO, 973467MY2, 973543MYO, 973926MYO, 978462MYO, 985643MG, 985873MG2, 985875MG, 989723MYO, A5405211, BCTECH2184116, BCTECH8278, CCCMYO1, CVIMYO, FHGAMYO, FRIMG1, MHLORGENM1, MSSTL-TBD16, RADNETNM1735, RADNETNM1743, RADNETNM1746, and VASMYO

Distribution pattern

United States: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,Guam,MA,MD,ME,MI,MO,MS,MT,NC,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR, RI,SC,SD,TN,TX,UT,VA,VT,WA,WI AND WV International: Albania, Argentina, Australia, Azerbaijan, Belgium, Bosnia ,Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Colombia, Cyprus, France, Germany, Greece, Guatemala, Honduras, Iceland, India, Iraq, Italy, Jamaica, Japan, Kenya, Korea, Macedonia, Mexico, Namibia, Panama, Peru, Philippines, Portugal, Russia, South Africa, Spain Switzerland, Taiwan, United Kingdom, Turkey, Venezuela and Vietnam

device · product 2 of 3

GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

Z-0370-2019
Recall number
Z-0370-2019
Initiated
September 14, 2018
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
1,166

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A detector can detach and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A detector can detach and fall.

Code information

System ID #: 334428MG, 256235NM2, 251660KWMG, 251410IMCMG, 501776MG, 870836MG, 870364MG, 479443MG1, 870261MG, 501520MG, 501614MC, 501224MC, 501686MG, 501202WMG, 870541MG, 501380MG, 479751MG, 501484MG, 479314MG2, 501474MG, 480393MG, 928758NM, 480425NM1, 602588NM2, 520GVHMG, 480830NM1, 928699MG, 602251NM2, 602588NM3,623478NM1, 480820NM1, 602392NM2, 623933NM1, 602870NM2, 623879NM1, 602964MG1, 480838MG, 480844NM1, 714456MG, 661663MG1, RADNETNM170, 661322MG, 909390MG, 707464NUC, 714979MG, 510792MG, 916537MG, 5668, 1572, 951698MG1, RADNETNM1732, 949863MG, 818885MG, 805988MG, RADNETNM1726, 626397MG, 30244MVC, 209835MG, 916781MG1, 415600DAVMG, 831759MG1, 831759MG2, 619287MG, 707576MG1, 408278MG1, 707546MG, 209944MC1, RADNETNM175, 310543MG, 310214MG, 707463MG, 818782MG, RADNETNM171, 626814MG, 530741MG, 30337NM, 719275MG, 719475MG, 970565MG, 303398MG, 303629MG, 303715MC1, 303715MC, 303673MG1, 303426MG1, 203797NM5, 203797NM7, 203797NM6, 203797NM4, 860364MILL, 860496MILL, 203238NM, 202529MC, 407303FAMC1, FHALTMG2, 407SMALMG, 407303FAMG1, FHAPMG, 561642MG1, 561642MG2, 561642MG3, 561742MG1, 813571MG, 718444MG1, 718444MG1, 239432MG, 727461MG, 727446MG, 305446MG, 305461MG, 352564XEL1, 863419MG2, 305529MG, 941473MG, 239938MG, 561468MG1, 850863MILMG, 352333MG, 352331MG, 305820MG, 305826MG, 904389MG, 904202OPMG, 407518MG, 07SMKSMG, 561795MGLW, 863680MG, 863687MG, 941368MG, 561791MG1, 321725MG3, 321725MG2, 305596B84, 305279MG, 305512EXL, 305821MG, 941436MG1, 850678TCMG, 352401WMMG, 352401MC, 352401MNM2, 352871NUC, 407303FSMG4, VACMG, 407SMKLMG, FHORLMG5, FHEMG, 904747MIL, 850747BMG, 850416SHMG, 850912VAMG, 954587MG, 954476MG, 561335MG1, 305251MG, 941342MG, 941951MG, 772SRMCMG1, 850325MG1, 941488MG1, 561798MG, 563927MG, 561863MG1, 407628MG, 407646WPMG, FHWPMG2, 407628MGA, 813991MG, 229312MG, 678762MG, 706208MC1, 404851MC, 403182, 404712MG, 706745MG, 706745MG2, 706625MG, 229276MG, 706278MG2, 404321MG, 706754NM, KAISERSW, KAISERGW, 770677MG, 912384MG, 404669NM, 770297NM1, 912757NM, 912751NM, 912765NM, 770793MG, 912454NM, 229890MG, 770991MG, 404605MG, 229391MG, 478922NM, 478922NM1, 671GMICMG, 808547QP3MG, 712792MG, 641236MMG, 712213MG, 712279MG, 319472MG, 319863MG, 208785MG, 208677MG, 208525MG, 207373MG, 618465MG1, 847382MG, 708783MG, 708923MG, 708923MG2, 630264MG, 708799MG, 630364NMMG, 504459MG, 309449MG, 815741MG, 847360MG, 815968MG2, 815968MG1, 815398MYO, 847933MG2, 847933MG3, 847941MG, 812933MG, 812256MG, 812485MG, 812485MG2, 812485MG3, 765281MG, 812858MG, 812752MG, 812237MG1, 812237MG2, 913367MG1, 620431MG, 620382MG, 913491DMG2 316421MG, 620421MG, 620221WNMG, 606833NMG2, 606833MG1, 606986MG, 270781MG, 270745MG1, 270793MG, 270745MG3, 270706MG, 270598MG1, 606573MG, 606439MG, 606666MG, 502893N6, 502636N8, 502361MG, 606598MG, 270926MG, 606337MG, 270725MG, 502633MG, 606678MMG, 606678NM, 502897MG1, 337898MG, 318473MC, 318473MG1, 225755MG, 225769MG, 225761MG2, 225231MG, 225761MG1, 225358MG, 985732MG, 337462MG, 337457MG, 985839MG, 504549MILL, 985230MG2, 985878MG, 504838MG2, 504838MG, 337261MG, 337521ACQ, 337289MG, 337289ACQ, 337475MG, 504454MG, 504888MG, 504456MG, 504456CCMG, 318371MG, 318812MG3, 318327MG, 337374MG, 504903MG, 504894MG, 337948MG, 318473MG, 318251GCMG, 318254MG, 504447MG, 337363MG, 318648MG, 318345MG1, 617754NM1, 413535MILL2, 413535MILL1, 301896MG, 443643MG, 301698MG1, 301373BEANMG, 301634MC, 301373MG, 207351MG, 586445MG, 313593MG2, 517851MG, 313593MG, 248471MG, 810732MC, 810733MG, 517437MG, 906774DMG, 248656MG, 989773MC, 586416MG, 906341MG, 906486MG, 248551MC, 989497MYO, 248945MG, 989846MG, 313295MG, 734671MG, 248828MC2, 313343MC, 248551MG, 248828MC1, 734467MG, 417869DMG, 417326MG, 417358ND2, 660259LMG, 409690MG1, 816271SJMG, 573468MG1, 417678MG, 636528MG1, 417256MG, 662712MG, 228467MG, 601824NM2, 601855MG1, 601853MG1, 228818SRMG, 228864MILLMG, 228863CHMC, 601740MG1, 362258MG, 662627MG, 662289MG1, 601815UMG1, 601853MIMG1, 601849MG1, 228809MG2, 662349NM, 662349NM1, 662349NM2, 662615MG1, 662841MG1, 601883NM2, 601883NMC1, 601735MG1, 406657DMG1, 406728MG, 919894MG1, CHOWANMG, 910483ACQ, ALLIANCESP37, 919784MG1, 336599MGA, 336718FMG1, 336718FMG2, 402483MG2, 402486MPR, 402473MG, 402873MG, 603432MG, 201858MC, 908277MG, 609465MG, 973625MG, 973989MG, 973702MG, 732548MG, 732390MG, 609655MG, 609358MG, 201795MC, 609978MG, 973898MC, 732545MG, 973971MG2, 856778MG2, 732745MG, 732745MC, 732745MG2, 973877MG2, 973877MG3, 973579MG, 732970MG, 973678MG, 201967MG, 973365MG, 201470MG, 201831MILMG, 732381MG, 732530MG, 609653MG, 732923MG2, 732923MG1, 505492MG, 505662NUC, 775738NM, 702564NM, 702384MMIL, 702896MG, 702240MG2, 702732MG2, 702240MG, 702732MG, 702346NM1, 775323MG1, 518438AIMG, 631968MG, 516829MG, 607337MG1, 845278MG, 718518MG, 718518GENIEXY, 718951MG, 718444MG, 718567MG, 718692MG, 718758MG, 718680MC, 716884MG1, 716857DW, 716895MG, 631277MG, 315SOSMG1, 845647MG, RADNETNM1745, 718869MG, 718762MG, 718670MG, 718670ENT, 718544MG, 516222MG, 315824MG1, 631351MG2, 631425MG, 718206MG, 716487MG, 716447MG, 716298MG, 315376LCMG, 315798MG1, 516775MG, 516562MC, 516327MC, 516869MC, 516562MG1, 212252MG, 212523MG, 212420MG, 212288MG, 212326MC, 212737MG, 212535MG, 212241MG, 212420MG1, 212420MG2, 212523MG1, 607432FMG, 631447XELERIS, 845858MG, 585922MG1, 845794MG, 315338MG1, 518347SMG, 914366MG2, 631726MG, 718876MG, 914368MG, 585786MG, 716630MG, 914964MILL, 330665MG, 513686MG2, 513686MG1, 21636307MG1, 419342MG, 614228MYO1, 740380MG1, 740845MG1, 614393NM, 440776MG, 330757MG, 440329MG, 419824NUC3, 330841MG, 330841MG1, 440414NM, 405779MG1, 405359EMG, 580355MG1, 580355MG2, 918683MG1, 405271OUMG1, 918523MG1, 918256MG, 918485MG1, 541OIT111A, 541994MG, 503535MG, 814946MG, 814949MG, 610954MG1, 610770MG1, 610954MG2, 215538MG, 814362MG, 215785MG1, 570645MG1, 215345MG1, 215345MG2, 215663MG1, 724752MG, 814868MG, 717657MG, 814247MG, 814532MY0, 814534MG2, 814837MG, 717820MG1, 412678MG, 724258MG, 215728MG1, 215707MG1, 215662MG1, 215331MG1, 215662MG2, 215728MG2, 215662MGP, 215827MG1, 412623MG, 570882MG, 724627MG1, 215648MG1, 401782MG, 864442MG, 803438NM1, 843784MG, 843681HHMG, 803431MG, 864529MG1, 864849MG1, 605224MG, 605322MOB1, 605882MILL, 931393NM1, 423877MG, 423778MG3, 423778MG2, 931551MG, 423778EDMG, 423775MG, 618357MG2, 423855MG, 615791MG, 423837MG, 423784MG, 423531MG, 423693MG, 865541MG, 865471MG, 865541ETCMG, 865471MG2, 731968MG, 731352MG, 731352HMG, 901346MG, 901226MG1, 901726MG, 901523MG, 423522MG, 615322NM1, 615583RRMG, 423481MG, 865481MG2, 865938MG, 731926MG, 806354NWMG, 817472MG, 217532NM1, 817599MG, 281837ALTUSMG, 409883MG, 979337MG, 361694DNM, 214879MG, 903675MG, 918825MG, 512942MG, 618357MG1, 618357MG3, 940384MIL, 972875MG, 817926MG, 817336MG, 817430MG, 972731MG, 409772NM4, 469999MG, 903408MC, 713785SLNM2, 713790LMC1, 936438MG, 281420MG2, 713463MG1, 713ACCMG1, 713785SLNM1, 713797NUC1, 972932MG, 214420MG, 972420MG1, 972420MG2, 903315MG, 915520MG, OPENMG, 915333MG, 713948MG1, 214739MC, 972781MC, 512446MG, 210572NM1, 210704MG, 210223MYO, 817778MG, 936266SLNM1, 281338MG1, 940766MG, VVMCMG1, 801492MG, 801357NUC3, 435722MG, 801268MG, 509747IMG2, 703558MYO, 434982MG1, 703698MG, LEEMG, 703689MG, 434517MG, 360754MG, 253697MG, 509942NUC, 206548MG2, 206223MG, 406782MG, 509525WWNUC, 608930MG, 608884MG, 262697MG, 920684MG, 414219MC 414647MG2, 414874MC, 262338MG, 414645MG, 414805MG, 414874MG, 608324MG, 262ISCVG, 262574MG3, 608745MG, 608723MG, 608776MG, 608647MG, 608873MG, 920262MG, 414569MG, 262544MG, 262574MG1, 262574MG2, 414259MG, 414777MG, 304255BMG1, 304637MG, 304697HNM, 304757NMG1, 304424NMG1, 304424GENIE, 304357MG, AL4009NM01, NM8464, 1795MILLMG, 3752MILENIUM, 94126MG, 910263209, 910262299, 910263176, 910262207, 910263214, 910262283, 0910263200, 910262098, 391884NU01, AH5117NU01, AP5816NM02, AP0338NU01, AH5653NU01, AZ4003NM01, 110093NU05, 210036NU04, 080038NU05, 070050NU02, 030006NU03, 030091NU06, 040158NU05, BA4030NM01, NM0791, 1316159, 2722518, 2837776, NM0964, 2702126, 2702287, 1189654, 2599328, 2657483, 2741212, 2954642, NM50904, 2685607, 78072, 2606818, 46200, 2854964, NM51699, 1339117, 2816349, 1337080, 1337071, 1319161, 2814934, 2726551, 2827678, 2833281, 2730895, NM639, 2730898, NM51698, 13645, 1205380, 1184323, 1218294, 2575410, 2614287, 2753164, 3082, NM51702, 13568, 13730, 53477, NM1446, 2540459-1, 24716, 14532, 2697006, NM08391, 2723506, 1167249, 2689272, 13831, 2799221, 2804878, NM51696, NM1462, 1186798, 1293331, 1343737, 1343738, 2814304, 2592294, 2836370, 2836369, 2628142-1, 780489MG2, 250545MG, 250727MMG, 780489MG, 416667MG, 705324MG2, 204942MG, 902496MG, 905727MG, 905791MG, 905791MG2, 416231MG, 519767MG, 905577MG, 705324MG, 519646MG2, 613727MG, 905895MG, 905684MG, 905723MG, 705745MC2, 705745MC, 416299MG, 416299SNMG, 519428MG, 807343CNUC3, 416813MG, 416284MG, 416465MG, 416438MG, 519206MG, 905430MG, 905576MG, 519254MG3, 519258MG, 519254MG1, 416593MC, 819357BMG,514842AMG, 514933MG, 514340MG, 514842AMG2, 514934BMG2, 514934BMG, 418628AMG, 819822MG, 32501257NM1, HNVNM1, 24205NM1, ,082426100010, 082426010005, 082426030006, 82426200006, 82426100014, 82426100004, 82426190009, 82426100022, 82426020003, 82426020004, 82426310018, 82426060002, 82426110005, 82426080013, 82426170002, 82426040040, 82426080015, 82426050006, 82426130028, 82426080017, 82426100039, 82426070026, 82426210018, 2802765MG, 2750131MG, 2625368MILL, 2751497BMG, 2866379AMG, 2866379BMG, 10094MILMG, 2774246MG, 2890503MG, 2751497AMG, 33815MMG, CY1114MN01, V9185605, HC0541NU02, PC3837NU03, PC3838NU04, 878339NU01, 878339NU02, PC3838NU05, PC3844NU03, 393115NU01 PC3874NU02, PC0850NU02, 543871NU01, HHAM02NU04, 540186NU02, 136413NU01, PKAI01NU03, HC5284NU01, 427459NU03, PC7625NU01, PC3720NU02, PC0995NU02, PC1961NU01, 673799NU01, PC1837NU02, PC2541NU03, PSAN01NU01, 509585NU01, HC0853NU02, H1349NUC01, H5059NUC01, H5899NUC02, H2049NUC06, H4390NUC01, H4262NUC14, H4105NUC06, H4935NUC01, H4093NUC03, H17642NUC4, 2767676, NM1471, 24574562NU, IS1002MN02, 83026843025441, 083026242100654, 083026240001716, 083026002002015, 83026102101026, 083026203255516, 83026002100286, 0002649858, 08302603017002, 083026802100897, 83026602100758, 083026604546814, 83026042100775, 83026042101847, 83026802101537, 083026800017715, 83026842100997, 83026841019810, 83026002101937, 083026022002249, IQ1575NM01, A5633804, A178956301, A268005103, A5132121, A5330712, A5162252, A5367605, A5165826, A5165828, A5186208, A200283801, B120559401, B5365420, B5365421, B5531603, A5251115, A5156933, A5142912, A5634503, A5151505, A5367807, A5124141, A397803504, A5636003, A5634102, D5822409, D5822413, C5123640, C5123632, A5114257, A5323502, A5115236, A5295811, A5278110, A5278112, A5138109, A5239806, A5660901, A5555211, A5634607, A5690905, A5690902, A5155147, A5221304, A5242702, 2543455NUCMED, YN1086, YN0536, YN0494, YN0906, YN0457, YN0830, YN2047, YN0903, YN0899, YN1094, YN0402, YN1103, YN8101, YN0831, YN0900, YN0433, YN2060, YN0394, YN0404, YN1090, YN2043, YN2046, YN0905, YN1092, YN2044, YN0627, YN1098, YN0537, YN0399, YN0828, YN2050, YN1099, YN1101, YN1102, YN0460, YN0466, KE1000NM01, 850260036, 0850260085, 850260053, MC1024NM01, 2615851MG, 2615865MG, 14NMMG2693065, 2750750MG, 2837597MG, 5449MILMG, 2762247MG, 589603MC, 2879861MG, 2825084, 2847091, 2860129, 8619NUCGS, 2851996, 2851997, 2851998, 2851999, 2859205, 2860131, 2860133, GELB0221MILLMG, NM50993, 870299MIL, 4422MIMG, 51485MG, NM51559, 2641677MG, 2763057MG, 70896MILMG, 9925MILMG, 4000711, NA1019NM01, 2673523MG, 2545894MILLEMG, 843260011, PER00431, PER10509, PER10516, PPS09402, PER10506, PER12107, PPR12211, PER08005, PER08614, PPS06901, PPR48810, PPR48801, PPR69605, 787653MILLMG, 809746MILLENIUM, 787757MILLENIUM, NM2595306MMG-1, RU1148NM01, RU1041NM01, RU1086NM01, RU1488NM01, RU1013NM01, RU1085NM01, RU1213NM01, RU1224NM01, RU2966NM01, RU3143NM01, RU1105NM01, RU1755NM01, RU1021NM01, ZA2425NM01, ZA2192NM01, ZA1829NM05, ZA1841NM04, ZA2391NM01, ZA2230NM01, ZA2693NM01, ZA2225NM01, ZA1818NM04, ZA2694NM01, ZA1442NM01, ZA2024NM04, ZA2692NM01, ZA1811NM06, ZA2813NM01, DPN43202, MPX43128, MP842028, MPX52304, MP221252, GPQ18703, GPQ14600, DEL26413, FP721A04, FP246604, MP601315, YP231727, FPG62103, FPG77501, NP473620, NPV15928, EEP03901, 750140NU01, 107010NU03, 853940081, 853260059, 0853940079, E06001NU03, 06008NUC07, 06002NUC05, 06002NUC06, 06004NUC02, 06052NUC01, 06063NUC01, 06074NUC01, 06087NUC01, 31015NUC01, Not Available, 34006NUC02, 34057NUC03, 34268NUC01, 34434NUC01, 46021NUC01, 55019NUC01, 67016NUC01, 00362NUC02, 38853104NMMET, 3882684835MNMET, 388553393NMMET, 388260005, 859260005, 859260007, and 859260006.

Distribution pattern

United States: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,Guam,MA,MD,ME,MI,MO,MS,MT,NC,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR, RI,SC,SD,TN,TX,UT,VA,VT,WA,WI AND WV International: Albania, Argentina, Australia, Azerbaijan, Belgium, Bosnia ,Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Colombia, Cyprus, France, Germany, Greece, Guatemala, Honduras, Iceland, India, Iraq, Italy, Jamaica, Japan, Kenya, Korea, Macedonia, Mexico, Namibia, Panama, Peru, Philippines, Portugal, Russia, South Africa, Spain Switzerland, Taiwan, United Kingdom, Turkey, Venezuela and Vietnam

device · product 3 of 3

GE Healthcare Millennium MC

Z-0371-2019
Recall number
Z-0371-2019
Initiated
September 14, 2018
Classification
Class I
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A detector can detach and fall.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A detector can detach and fall.

Code information

System ID #: 870735MG, 928333WMM02, 970635MYO, 203576DNT, 407896FMG2, 954634MG, 316267KCN, 601883NMC2, 910483XEL1, 910296MMG, 908277XL2, 908277MG2, 908218MYO, 918496EN1, 972759CROWNMG, 940566MG, 972434MC,and 972473MYO.

Distribution pattern

United States: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,Guam,MA,MD,ME,MI,MO,MS,MT,NC,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR, RI,SC,SD,TN,TX,UT,VA,VT,WA,WI AND WV International: Albania, Argentina, Australia, Azerbaijan, Belgium, Bosnia ,Herzegovina, Brazil, Canada, Chile, China, Costa Rica, Colombia, Cyprus, France, Germany, Greece, Guatemala, Honduras, Iceland, India, Iraq, Italy, Jamaica, Japan, Kenya, Korea, Macedonia, Mexico, Namibia, Panama, Peru, Philippines, Portugal, Russia, South Africa, Spain Switzerland, Taiwan, United Kingdom, Turkey, Venezuela and Vietnam