Exact FDA event identifier

Event 91139

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

Event summary

Timeline bucket: November 10, 2022
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

8 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 8

Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0752-2023

Recall number: Z-0752-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 5,649 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

Model Number (System ID): H45021LC (VS50873, VS51169, VS5227, VS594, VS5289, VS544, VS5155, VS50058, VS519, VS551, VS50589, VS5286, VS5317, VS5299, VS50954, VS50940, VS560, VS50793, VS50311, VS50028, VS5125, VS50648, VS50721, VS50851, VS5300, VS5224, VS516, VS5306, VS50097, VS50154, VS50841, VS50513, VS5294, VS5151, VS50908, VS5511, VS5169, VS50746, VS50795, VS50816, VS50895, VS51008, VS50750, VS5304, VS5297, VS5495, VS50634, VS5874, VS50830, VS50931, DZ1270US01, AZ4001US03, AZ4002US01, 130083US09, 629782US01, 220909US02, 190282US07, 190282US08, 030232US18, 030232US19, 030151US07, 030151US06, 030151US05, 624025US01, 030488US01, 190226US06, 852578US02, 110009US05, 190902US02, 550020US03, 030024US01, 100029US06, 110014US31, 110014US06, 030800US16, 110019US17, VS5146VS5, VS50530VS5, VS5194VS5, VS5133VS5, VS5147VS5, VS5545VS5, 2830213, LP594207SU8, VS5176VS5, VS50166VS5, BG4607US01, BG4576US01, BG4037US08, BG4000US03, 519631VS5A, VS5907VS5, 2829006, 082438090140, 082438070046, 082438070047, 082438070048, 082438070049, 082438160195, 082438090155, 082438220037, 082438030051, 082438070167, 082438090130, 082438160116, 082438300015, 082438070077, 082438110042, 082438210055, 082438070057, 082438070058, 082438070059, 082438070060, 082438070061, 082438070062, 082438100143, 082438030053, 082438110052, 082438160151, 082438100141, 082438130066, 082438130068, 082438130073, 082438050028, 082438110051, 082438210045, 082438090159, 082438100142, 082438080029, 082438090156, 082438090167, VS50488VS5, VS50778VS5, HR4097US03, HR4177US01, HR4180US01, CZ6251US01, CZ6048US02, CZ4047US07, CZ6301US01, CZ6325US01, CZ6242US01, CZ6274US01, CZ6311US01, CZ6156US02, CZ4184US03, CZ6265US01, CZ6147US02, CZ4031US22, CZ6470US01, CZ4031US20, CZ4054US02, CZ6255US01, CZ6324US01, CZ4186US02, US55001907, US26650207, US73018012, GP1091US01, USM4166003, UB03108415, U579936801, U198770201, U347902301, US26119915, US87998919, U205630901, USA2761502, U140071302, USM2722406, USM2722407, U326367301, U203176801, US78044203, US15012704, U195829506, MQ1074US08, MQ1078US02, USM4475108, US29019103, U422329701, USM4178501, USM4498901, USM5486414, U205066601, U210312101, US70535402, US85954914, USM4186001, US55554105, U356794301, U201768601, US26659904, US29081309, UG04440402, U394617101, U361473101, US62749602, USM4488005, USM2848804, US95957102, UN15805301, US29072702, U356443301, US29088506, US70650802, U211635401, U244620302, US20768609, USM4464424, US68233304, GP1091US1, U411411901, US78044306, U203184204, U586840901, USN4858901, US62899102, USM4209506, U159630005, USB4440401, U211358601, US85870003, US80003003, U104747904, U210534202, 1790320U02, 145362U014, 141326U464, 113288U004, 1700906U04, 1700906U02, 148248U006, 1078247U05, 141825U011, 2139939U01, 2152178U01, 2009660U01, 2026394U09, 138047U012, 2015218U01, 120008U021, 112014U006, 150228U006, 109544U011, 1198306U02, 800933U003, 1530078U03, 2613970U01, 2110472U01, 145287U012, 145287U008, 106989U031, 801296U004, 100019U018, 391401U002, 110305U025, 118965U006, 2178160U01, 151066U005, 2116317U01, 107041U006, 2028862U01, 109024U004, 141785U154, 2404081U02, 800626U004, 146221U003, 2099261U01, 110332U014, 11959AU164, 141349U002, 2039531U01, 141904U004, 149092U007, 110408U009, 1937574U03, 2009258U03, 803630U003, 2001341U01, 140141U008, 148030U007, 2047938U02, 2112894U01, 2031290U01, 110826U006, 138004U002, 104484U002, 117979U003, 110162U015, 148267U003, 2121342U01, 110235U007, 119436U047, 2127044U01, 138792U009, H10345US01, H1034US04, H2003US13, H10344US03, H10341US02, H2052US15, H1969US16, H4135US02, H5108US01, H10343US02, H1462US02, H4975US01, H5002US01, H5074US01, H4242US02, H6625US01, H5015US01, H1817US02, H1255US02, H4972US01, H4987US01, H4873US01, H4187US02, H2068US11, 0828380117, 0828380121, 0828380122, 0828380125, 0828380129, 0828380231, 0828380273, 083038005104609, 083038245101139, 083038065005319, 083038865101289, 083038869051919, 083038607184217, 083038602043514, 083038603185414, 083038604935414, 083038605602915, 083038821010510, 083038825041514, 083038825101529, 083038841016814, 083038285101598, 083038601826610, 083038604021310, 083038869050298, 083038065104959, 083038604709109, 083037804035913, 083038005104278, 083038064026312, 083038845004309, 083038848181849, 083038844413412, 083038285105349, 083037045003759, 083038045102069, 083038045104068, 083038045002079, 083038600323813, 083038800053512, 083038865103608, 083038609040369, 083038869051298, 083038825103238, 083038005102439, 083038005004729, 083038005103588, 083038005102668, 083038005105639, 083038846176810, 083038045102688, 083038245105009, 083038869052079, A5205029, A5936402, A6052501, A6036201, A212055401, A6429501, A6093202, A200858801, B5803119, A6014101, A5231606, A5290819, A5290821, A5368801, A5656002, C5165836, C5165837, A5920303, H5401507, A6051801, A5645321, G5401518, A5235606, A5204007, A150264808, A150264807, A5153615, A6025601, A6035701, A6251301, A6001901, A6020101, A5684307, A5681811, A5913304, A6022701, B5580612, A6255101, A6038501, A5194090, UXA093, UXA108, UXA095, UX9097, UX9107, UXA096, UX9101, KA3179US02, 0850US6317, 0850US6459, 0850US6121, 0850US6277, 0850US6350, 850376797, 0850US7299, 0850US6278, 0850US6188, 0850US6152, 0850US6355, 0850US6705, 0850US6090, 0850US6512, 0850US6591, 0850US5793, 0850US6625, 0850US6534, 0850US6190, 0850US6980, 0850US5618, 0850US6738, 0850US5985, 0850US6189, 0850US6298, 0850US5604, 0850US6318, 0850US6487, 0850US6834, 0850US6386, 0850US6723, 0850US6763, 0850US6218, 0850375081, 0850US7060, 0850US5603, LT4076US01, LT4000US23, 200012US07, 2877933, 2877927, 0843384078, 0843384079, 0843384081, 0843384082, 0843384083, 0843384085, PL2413US01, PL7007US01, PL1667US01, PL2146US01, PL7116US04, PL2320US01, PL2216US01, PL1171US02, PL1026US03, PL2446US01, PL3169US02, PL1919US01, PL1712US01, PL2701US01, PL2148US01, PL7436US01, PL7445US01, PL7052US01, PL1891US02, PL1856US03, PL8538US01, PL7986US02, PL7121US01, PL2213US01, PL7097US01, PL2132US01, PL7435US01, PL7046US01, PL4415US05, PPR100701, PPR103001, PPR16006, PPR104100, PPR03703, PPR98711, PER37006, PPR50201, PPR90608, PER06633, PPR52402, PPR64608, RO4084US03, RO4406US01, RO4764US01, RO4388US01, RO4384US01, RO4305US03, RO4349US01, RU3324US01, RU2296US01, RU3024US02, RU3341US01, RU6584US01, RU5411US02, RU5413US02, RU2668US02, RU6534US01, RU1282US12, 600101US05, RU3391US01, RU6336US02, RU6486US01, RU6448US02, RU6629US01, RU5033US02, SN1030US02, 0847374284, 0847384074, 0847384077, SK4196US01, SK4215US01, SK4249US01, SI4080US01, SI4087US02, DED33120, FPG63903, FEG37712, FPG95900, UE226232, NPV79800, CP749705, MEX68700, GPX28800, CPZ21101, NPV27002, YP630020, DEH13560, FEF70533, EE238530, CP569311, MP926413, UPW30100, YE645843, FPG98800, EPP07901, UPW30400, NE419138, CEE15682, UP644118, EPP01100, EPP01000, 0856380095, 0856380140, 0856380139, 0856380112, 0856380113, 0856380111, 06126ULT08, P21037UL01, 46012ULT01, P26031UL01, 00036ULT01, 30006ULT01, P34500UL03, 34270ULT05, P34500UL01, P34500UL04, P34500UL02, 34030ULT09, 34705ULT14, 34199ULT01, P34500UL05, P71003UL07, 859384027, 859384026, 0859384018, 0859384022, 0859384025, 0859384029, 0859384030); H45021WA (VS5R0104, VS50815, VS5143, VS50883, VS545, VS50164VS5, 2102072U01); H45031DX (VS52100, VS52210, VS51573, VS51873, VS5R0050, VS51552, VS52206, VS52201, VS51655, VS51954, VS51888, VS51476, VS51041, VS51047, VS52033, VS51458, VS51426, VS5R1042, VS51992, VS52207, VS51969, VS52083, VS51821, VS51421, VS51837, VS51672, VS51413, VS50309, VS51617, VS52195, VS51418, VS5U3112, VS52110, VS51017, VS51813, VS52205, VS51610, VS50988, VS51505, VS52116, VS52098, VS52115, VS51930, VS51014, VS51886, VS52096, VS52099, VS51832, VS51835, VS52198, VS51973, VS51991, VS52208, VS50818, VS50974, VS51898, AL4014US01, AH5702US08, AP6708US02, 695743US01, 487483US02, 010307US04, 040335US02, 220078US24, 030220US09, 030308US01, 030295US08, 220108US05, 220826US02, 200025US08, 060946US02, 080044US09, 030006US01, 030360US03, 520671US01, 100032US06, 110005US03, 200047US03, 274648US02, 660198US01, 110094US06, 671999US01, 080100US06, 110019US18, VS5150VS5, BG4612US01, HR4210US01, HR4026US08, CZ4112US07, CZ4147US03, CZ4165US01, CZ6318US01, CZ4046US03, CZ6520US01, CZ4010US12, CZ4042US03, CZ6317US01, DK1083US46, DK1051US20, U218790801, US29072404, USM4220401, U102211303, U221116201, U104546805, USM8014203, USM1682003, US87959204, U185624402, U229042301, U205627102, US20004205, US59469202, USA2761504, USM6075701, USM4170806, U223279701, USM4150211, USM4171501, UO55319603, USM4432504, U126446610, US29030606, US72063305, U171681002, U154358403, USM4173823, US41748006, U195829516, MQ9999US03, MQ9999US06, U151061208, U221845301, USM1702204, U220786601, U10002002, U429701401, US26357806, USM4154406, USM4154402, USM4625306, US88078101, MQ1073US03, U232642301, USM9481811, US12019806, US88657314, U179036802, US15001504, USM4487207, USM4187008, GP1107US02, USM2314204, US13024601, US32226803, U342175501, U233125701, US26366604, U216577201, NC1043US02, U444305402, U444305401, U226458101, US96628201, U218513401, USM2606003, GP1038US03, GP1038US3, US75015404, USM4484108, U221302501, USM4489303, RE1000US01, PM1000US01, USN4201601, U231483301, US26478709, USM4205002, US26487405, U233125301, RE1179US01, U198324002, U217877201, US80004505, USM4433001, U232429902, U232429901, US85870004, US26491411, U122733002, 110185U005, 138702U009, 2237379U02, 2337235U04, 141326U711, 118962U006, 2477366U01, 138047U014, 1464242U04, 2364245U01, 2248607U01, 2183766U01, 149302U004, 109529U064, 109529U065, 149523U003, 113023U037, 2161146U02, 4683358U01, 112072U015, 112027U011, 2375239U01, 110051U008, 1963358U01, 1020149U03, 1837410U06, 145760U011, 112099U009, 107006U031, 112307U019, 107006U033, 106444U008, 110305U030, 1882626U06, 145080U005, 122006U025, 2177234U01, 141761U003, 2335973U01, 120087U006, 1040261U01, 148188U005, 1030410U01, 3554433U01, 1957675U02, 142282U005, 145771U028, 2247681U01, 124811U007, 2294975U01, 120032U054, 149092U008, 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LT4036US03, LT4082US01, LT4084US01, MC1024US04, NO4170US03, PL7572US01, PL7352US01, PL0706US02, 600036US05, PL7606US02, PL1894US02, PL2114US01, PL1916US02, PL4533US02, PL7556US01, PL6393US05, PL1874US02, PL7566US01, PL7300US01, PL1222US06, PL7511US02, PL8507US01, PL6292US02, PL7417US01, PL0146US02, PL2071US01, PL7516US01, PL3682US01, PL7478US01, PL7944US01, PL7489US01, PL7599US01, PL7569US02, PL1858US02, PL4675US01, PL2498US01, PL3627US01, PL7339US01, PL7340US01, PL6170US06, PL0373US01, PL7299US01, PL4683US02, PL1931US01, PL4415US08, PPS05709, PPS01300, PPR15514, PPR110203, PPR49902, PER33503, PPR54603, PPS00801, PER18119, PER00725, PPR74705, PPS08103, PER28132, PPR65201, PPS26200, RO4920US01, RO4231US01, RO4334US05, RO4513US01, RO4484US01, RO4434US01, RO4200US03, RO4434US03, RU1556US30, RU1448US02, RU1109US01, RU4337US04, RU3461US01, SA1235US06, SK4258US01, SK4006US03, SK4303US01, SK4279US01, SK4206US03, SK4283US01, SK4281US01, SK4288US01, MPX62501, FEC800180, FE421158, NE300607, FEB34238, FEB34259, CEZ08107, UE255925, 0856380114, 0856380130, P33043UL06, 00013ULT13, UA4261US02); H45031DZ (VS51619VS5, VS54088VS5, VS54083VS5, VS55139VS5, VS52112VS5, VS52113VS5, VS52107VS5, VS51502VS5, VS51597VS5, VS51598V5, VS53846VS5, VS52532VS5, VS54077VS5, 0911365579, AP5187US03, AP6141US02, AH5702US09, AP2900US03, AP0519US12, 497634US02, 994924US03, 080092US07, 270578US02, 671266US01, 270528US02, 682481US01, 040187US04, 040909US02, 110034US07, 665267US01, 100032US05, 656028US01, 030070US05, 300013US05, 654100US01, 780484US03, 040040US02, 030029US09, 270561US03, VS53573VS5, VS58132VS5, VS52437VS5, VS51985VS5, VS5145VS5, VS51844VS5, VS51891VS5, VS51903VS5, VS5148VS5, VS5134VS5, VS51850VS5, VS51897VS5, VS51814VS5, VS5122VS5, VS52545VS5, VS5144VS5, VS51638V55, VS51896VS5, VS5140VS5, VS51894VS5, VS52543VS5, VS57008VS5, VS5117VS5, VS51958VS5, VS53184VS5, VS51603VS5, VS51944VS5, VS51870VS5, VS55045VS5, VS51947VS5, VS51406VS5, VS51899VS5, VS51945VS5, VS51769VS5, VS51880VS5, 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PL3540US02, PL8142US01, PL7622US01, PER30603, PPR104708, PPR47515, PPS12200, PPR52502, PPS07000, PER19511, PPR52602, PPR74102, PPR84701, PER06529, PPS03500, PPS03000, PPR63808, PPS07200, PPS33300, PPR58001, RO4519US04, RO5122US01, RO4334US07, RO4750US01, RO4746US01, RO4772US01, RU3718US02, RU2262US02, RU7290US01, RU1168US05, RU3644US03, RU7950US02, RU3688US01, 600101US06, RU7381US01, RU7638US01, RU1175US06, RU7219US01, RU7347US01, RU7431US01, RU7473US01, RU6372US02, 6073UL0065, 6073UL0025, 0847384176, 0847384236, 0847384237, SK4512US01, SK4039US04, SK4448US01, SK4295US01, SK4353US01, SI4053US08, SI4218US01, SI4103US01, SI4056US08, SI4108US01, MPX70601, MP510803, DEM88516, GPX31600, GP178333, CE561239, MPX06600, DE203272, DPH65225, FPD04300, MPX85801, MEX689135, UE148618, GPX23901, DPN16201, NEV439184, 083038802003112, 220175US01, 0856380197, 0856380212, 0856380216, 0856380217, 0856380228, 0856380229, 0856380234, 0856380237, 0856380241, 0856380253, 0856380280, 0856380266, 10627ULT01, 0859384006, 0859384008, 0859384009, 0859384017); H45031XR (VS6445, VS6158, VS6116, VS6369, VS6443, VS6499, VS6357, VS6462, VS6345, VS60874, VS60829, VS60828, VS60822, VS60837, VS60833, VS60767, VS60806, VS60832, VS60856, VS60869, VS60721, VS60820, VS6448, VS60846, VS6MB0091, VS6MB0565, VS6MB0406, VS60798, VS60824, VS60825, VS6310, VS6259, VS6309, VS6280, VS60632, VS6257, VS60351, VS6327, VS60915, VS6600, VS60157, VS60135, VS60067, VS695, VSR6365, VS6262, VS60543, VS6227, VS60346, VS6450, VS60300, VS6358, VS60810, VS6128, VS60705, VS6367, VS6455, VS6133, VS6376, VS6433, VS60081, VS60826, VS60573, VS6R0209, VS60555, VS6416, VS6364, VS6R0355, VS60537, VS60228, VS60639, VS676, VS6289, VS60586, VS64123VS6, VS64064VS6, VS53506VS5, VS53751VS5, VS53870VS5, VS64000VS6, VS63992VS6, VS64057VS6, VS64043VS6, VS67346VS6, VS53888VS5, VS64032VS6, USM4461403, U151406402, US85954913, US26674613, USM4196601, U203062601, U180555404, 110636U005, 803212U004, 138977U004, 149093U003, 118254U006, 151234U002, 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122012U027, 1898210U01, 145771U026, 144238U023, 2099364U01, 1931320U01, 102551U006, 1480360U01, 110923U013, 105021U004, 102007U009, 149657U021, 149657U020, 141421U005, 144666U002, 2035406U01, 120032U040, 120034U021, 110780U001, 1965922U03, 3385427U01, 149687U006, 210103U002, 109537U007, 7494355U03, 2077049U01, 2041154U01, 103013U019, 146589U006, 110105U008, 110105U009, 107088U005, 145924U002, 145272U025, 148000U008, 5112400U01, 138963U008, 2041050U01, 138160U002, 138818U002, 120102U004, 804257U003, 145604U003, 1970580U01, 109045U019, 119436U045, 2223323U19, 110189U007, 110189U006, 2017571U07, 2017571U04, 112085U013, 2017571U03, 2047259U01, 142538U013, 142538U010, 142538U012, PL1696US02, PL3233US01, PL8150US01, PL3052US03, PL3013US01, PL0072US01, PL1751US03, PL2278US03, PL3109US01, PL3161US01, PL3206US01, PL3097US02, PL0021US02, SI4079US03, SI4136US01, SI4056US05, SI4089US01, SI4089US05, SI4089US03, O032US001, 801097, 10847ULT01); H45041C (083038603680917, 083037281041013, 083037808675112, 0850US7960, 0850370069, 0850US7510, 0850US7822, 0850US7977, 0850US7704, 0850370045, 0850US7786, 0850US7779, 0850370479, 0850US7903, 0850US7495, 0850US7895, RU1518US07); H45041CR (VS54169VS5, VS53385VS5, 0911373622, AH6388US01, AH4001US64, AH4323US47, AP7155US01, AP7251US01, 110065US24, 110065US27, 110965US01, BA4073US13, BA4073US12, BA4204US01, VS57002VS5, VS55218VS5, VS55227VS5, VS57113VS5, VS55206VS5, BG4644US01, 082438040173, 082438230101, 082438230108, 082438230094, 082438020038, 082438110076, 082438160308, 082438160261, 082438160277, 082438090208, 082438100213, 082438260022, 082438260023, 082438260024, 082438260025, 082438120403, 082438090286, 082438210085, 082438160319, 082438200024, 082438210082, 082438010059, 082438210080, 082438090204, 082438190042, 082438160310, 082438090224, 082438100234, 82438210093, CZ6028US05, CZ4098US03, CZ4047US09, CZ4051US02, CZ6082US03, CZ6435US01, CZ4031US26, CZ6393US01, CZ4018US04, DK1044US79, DK1086US08, DK1054US42, VS55196VS5, FI1063US15, FI1507US04, FI1128US36, FI1288US02, USM4159208, U266230801, US80003404, USM4476513, US63632006, UM50000301, U257927401, US15001604, U106228102, US61709104, U239027702, US87959207, USM4167405, U239812701, US27069207, US38565501, U256911201, US87682313, US87682312, U130335302, U252907401, US77879502, USM1901902, U231429101, U251493201, U246146901, USM2858702, USM2858703, U241386701, USM4500616, U24368401, U152870605, U156244205, USM2852703, USM4463918, US78046003, U263588601, U211379802, USM4482701, M2424619, U254221801, U451417901, US27508708, USM5485202, U356794302, US55100201, US16610801, USA5315003, U255490401, US26674619, U263715601, U203665503, USM2503704, U129361403, USM2503703, U250393801, U245334101, U266232601, UG64353002, US29040804, U246382901, US86070202, U262571802, U239632501, USM1244501, USM2820512, USM4464414, USM4202502, UA4213104, US26478013, US88033807, US88033808, U255975201, US29094803, US15000305, U202810004, USM7417503, U222842501, U119044602, U422108302, U218769402, U216610801, U176551403, US62898903, US94752311, US94752540, US94752567, US94752570, US26491110, USM4216607, USM4216711, U247517501, USM4217604, 210030U004, 150382U002, 2508073U01, 110984U008, 120246U009, 138756U006, 110906U020, 110906U014, 110033U007, 145812U011, 145741U002, 141915U002, 120707U002, 2410403U01, 2410403U03, 210047U004, 123017U023, 2677858U01, 1519548U04, 148102U009, 120631U002, 2552358U01, 120068U006, 2339163U01, 150358U003, 145749U004, 112013U013, 112013U014, 4171891U01, 145714U001, 1412224U02, 149869U005, 145135U020, 110740U002, 138047U017, 2630252U01, 2404012U03, 2559290U02, 109007U006, 2588748U01, 110443U008, 110443U009, 2550896U01, 103135U032, 109860U003, 151242U008, 3840379U01, 138902U001, 151244U003, 1571900U02, 2680181U01, 2586319U01, 2403325U01, 104007U033, 5041122U01, 109529U068, 110809U003, 408265U002, 2947444U01, 1935372U02, 110100U002, 2451765U01, 140417U004, 1292507U10, 148004U002, 145384U024, 9003278U01, 142494U004, 142494U003, 110491U005, 145223U010, 1837410U18, 100540U014, 1837410U35, 1837410U37, 146573U003, 106444U009, 4208447U04, 391401U003, 1810404U04, 2477672U01, 1882626U09, 148131U004, 803588U006, 109305U008, 120019U024, 109305U009, 117961U003, 110284U011, 125085U03, 110130U004, 122006U039, 124618U003, 2663848U01, 148006U008, 138495U009, 112092U008, 117955U003, 2443579U01, 144572U005, 200003U003, 149025U006, 119083U009, 122009U055, 109532U002, 109634U048, 1965936U09, 1965936U11, 2613294U01, 110933U029, 149750U012, 149750U010, 149750U009, 802077U004, 120524U004, 1685347U14, 210096U005, 145766U005, 141077U003, 145771U039, 2338561U01, 1266381U02, 140237U003, 104035U017, 103302U053, 110923U018, 2516552U01, 105021U008, 1737356U04, 2498496U01, 110107U013, 117970U003, 110426U007, 138035U016, 2139981U16, 803248U003, 117034U005, 2514814U01, 110197U008, 2520328U01, 802505U003, 148030U008, 2593698U01, 110690U008, 800470U003, 2612346U02, 2355727U01, 802501U013, 148089U005, 2190372U01, 1541174U02, 110119U020, 120040U012, 145463U004, 101053U007, 112191U034, 149722U009, 2448971U01, 103301U768, TP9041U019, 109725U011, 109725U010, 1202882U02, 110510U002, 120053U014, 2811240U01, 804257U004, 109045U022, 119436U059, 150163U009, 112600U008, 148034U004, 109387U003, 140595U002, 1077178U02, 143422U001, 138792U012, H2069US04, H2083US01, H2095US06, H4052US02, H6129US02, H5666US01, H5849US01, H5528US01, H5681US01, H5468US01, H5653US01, H5605US01, H4451US02, H5655US01, H5705US01, H5587US01, H4255US02, H5415US01, H5543US01, H4077US10, H4043US02, H5665US01, H4564US02, H5457US01, H5547US01, H5489US01, H5480US01, H5750US01, H4449US02, H5406US01, H5622US01, H5425US01, HU1245US02, HU1488US01, HU1042US04, HU1042US07, HU1127US03, HU1058US03, HU1202US04, HU1578US03, 083038241087013, IL4710US05, A62

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.

device · product 2 of 8

Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0753-2023

Recall number: Z-0753-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 5,145 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

Model Number (System ID): H45021LD (VS6R0610, VS60368, VS6253, VS6229, VS60870, VS60838, VS627, VS671, VS6332, VS60647, VS629, VS60084, VS6302, VS674, VS6423, VS6411, VS6R0161, VS6634, VS682, VS60841, VS694, VS6341, VS6R0202, VS67633, VS5956VS5, BG4575US01, 604557VS6A, 819732VS6, 403541VS6A, 905523VS6, 416431VS6A, 905884VS6A, 647938VS6A, 705674VS6B, 705674VS6A, 604588VS6B, 604588VS6A, 416597VS6, HR4052US04, HR4179US01, CZ6302US01, CZ6267US01, CZ4031US21, CZ4024US08, CZ6112US02, CZ4031US18, CZ6256US01, CZ6240US01, USM4474502, 145865U002, 120008U030, 2195878U01, 142540U001, 2090670U02, 105827U235, 1926826U02, 818670U341, 800830U451, H1039US19, H2015US20, H4044US04, H1383US33, H2115US05, H4850US01, B5343402, LV4046US01, LT4001US05, LT4000US28, LT4070US01, LT4000US26, LT4000US25, ALR0440, AMS1047, AMS1046, GRN01412, GRN01411, GRN01410, IJM0240, LDN0170, UTR2141, PL2263US01, PL1736US03, PL1623US01, PL2217US01, PL1107US02, PL1006US06, PL1893US02, RO4159US02, RO4341US01, RO4334US02, RU1591US10, RU1106US22, RU1295US14, RU1295US15, RU1018US12, RU1695US02, RU3298US01, RU3299US01, RU1653US02, RU3431US01, RU1553US03, SK4206US02, SI4077US02, SI4077US03, SI4077US04, MPX76304, ME597504, A020US07, P31025UL05, 26011ULT04, 27005ULT06, 45009ULT01, 48015ULT01); H45021LJ (VS600103, VS61226, VS6329VS6, 082438070075, 082438070090, 082438160133, 082438180028, 082438090132, 082438090133, 082438090134, 082438220039, 082438290035, 082438010038, 082438150038, 082438160106, 082438180032, 082438180048, 082438270034, 082438270035, 082438270033, 082438070063, 082438290036, 082438290040, 082438220027, 082438210053, 082438160154, 082438130074, 082438130065, 082438130071, 082438130079, 082438140075, 082438070083, 082438050033, 082438140088, 082438210057, 082438310058, 082438310064, 082438280007, 082438290044, 082438160119, 082438160166, 110256U011, 2258373U01, 083038821002811, 083038841101714, 083038065102678, 083038105104829, 083038005104569, 083038005746413, UX9054, UXA012, UX9053, UXA028, UXA100, UX9098, UX8014, UXA009, UXA042, UX9090, UXA073, UXA024, UXA033, UX8032, UX9088, UX8034, UX8026, UX9077, UX9085, UX9057, UXA029, UX9092, UXA017, UXA001, UX9064, UX9066, UX8021, UX9079, UXA002, UX8005, UX8019, UX8008, UX9078, UX8044, UX9062, UX8036, UX8037, UX8049, UXA020, UX9068, UXA047, UX9087, UX9052, UX9051, UXA072, UX8018, UXA048, UX9060, UXA075, UX9081, UX8035, UX9086, UXA045, UX8003, UX8040, UX8007, UX9063, UX8004, UX8041, UX9061, UX9056, UX8025, UX9084, 0843384096, PL1232US03, PER13818, RU7430US03, RU3297US01, 0856380121, 34197ULT01, VS6578VS6); H45031EB (VS61302, VS6918, VS60793, VS61205, VS62007, 6061, VS61308, VS61866, VS61128, VS6R0695, VS61502, VS61498, 5864, 6120, VS61126, VS61420, VS60960, VS60361, VS60344, VS61334, VS61137, VS61830, VS61179, VS61740, VS61095, VS61331, VS6R0359, VS61213, VS6MB1686, VS6MB1339, VS6R1049, VS61115, VS60965, VS60988, VS61140, VS61244, VS61315, VS61345, VS61839, VS61231, VS61474, VS60994, VS61344, VS61033, VS60980, VS61941, VS61988, VS61968, VS60972, VS6666, VS61121, VS61116, VS61630, VS61629, VS60983, VS60999, VS61199, VS61098, VS60267, VS62160, VS61131, VS61953, VS61134, VS61012, VS61811, VS61211, VS61249, VS61592, VS61596, VS61449, VS61109, VS61318, VS61989, VS61100, VS61197, VS61441, VS61432, VS61283, VS61380, VS61317, VS61603, VS61585, VS61826, VS61661, VS61635, VS61939, VS61293, VS61007, VS61014, VS61437, VS61426, VS61374, VS61645, VS61299, VS61608, VS61364, VS61384, VS61371, VS6MB1248, VS63929VS6, 091136DEMO2467, 0911367150, AP5187US04, AP8694US01, AP0514US02, AH5287US10, AP0341US01, AP6694US01, AH0132US31, AH0132US32, AH0132US33, AP7099US01, AH0101US76, AH5848US61, AH4660US28, AH5848US57, 140024US18, 080053US03, 010028US02, 030344US02, 686348US01, 220166US14, 110037US13, 210002US44, 090009US02, 030018US07, 300013US06, 030029US08, 030029US10, 2847741, VS68335VS6, VS63428VS6, VS63748VS6, VS62261VS6, VS61716VS6, VS61568VS6, VS63483VS6, VS63225VS6, VS68332VS6, VS61721VS6, VS63147VS6, VS63677VS6, VS63676VS6, VS63514VS6, VS63018VS6, 87197, VS61963VS6, VS63115VS6, VS63125VS6, VS61590VS6, VS65149VS6, VS63609VS6, VS62386VS6, VS61560VS6, VS63098VS6, VS62201VS6, VS63119VS6, VS61253VS6, VS69174VS6, VS62008VS6, VS63215VS6, VS67791VS6, VS63735VS6, VS63188VS6, VS63626VS6, VS63789VS6, VS61713VS6, VS61582VS6, VS61703VS6, VS63264VS6, VS63207VS6, VS63262VS6, VS62242VS6, VS60613VS6, VS67660VS6, VS63263VS6, VS63121VS6-1, VS63674VS6, BG4553US01, 705435VS6A, 403719VS6B, 705869VS6A, 416748VS6A, 905472VS6A, 905828VS6A, 514843AVS6B, 514281VS6A, 514876VS6A, 514340VS6A, 514845VS6A, 519372VS6A, 519426VS6A, 905735VS6A, 905688VS6A, 705494VS6, 519254VS6B, 416921VS6, 416422VS6A, 416586VS6A, 519254VS6A, 519250ECHOSW3, 519258VS6A, 204787VS6A, 519973VS6A, VS64441VS6, VS65095VS6, VS63642VS6, VS64388VS6, VS63219VS6, VS63901VS6, VS63996VS6, VS67452VS6, VS62086VS6, VS63492VS6, VS63967VS6, VS64011VS6, VS63965VS6, VS64114VS6, VS61451VS6, VS61463VS6, VS61166VS6, VS62013VS6, VS63353VS6, VS62155VS6, HR4208US01, HR4053US02, CZ4017US39, CZ6402US01, CZ4037US03, CZ6099US02, CZ6355US01, CZ6307US02, CZ6362US01, CZ6403US01, DK1083US45, DK1179US03, DK1098US04, DK1007US12, DK1106US12, DK1042US18, DK1264US01, FI1313US12, FI1349US01, FI1128US25, FI1128US29, FI1014US07, FI1014US08, FI1018US06, USM4162506, USM4478101, USM4478403, U98381329, US70725812, US87682305, US87682306, U201476602, USM4480410, UO55319606, US88069801, USM4023013, USM2266802, USM2173204, U187868406, U195829531, US26664717, US26664716, USM1293303, U206685902, US55554106, US48270615, US48270616, US48270617, USM4048013, USM4048011, USN4165416, USN4191201, U233125702, US77608102, USM4488007, UM75732304, UM75732303, U200487603, U227680301, U232975501, US38390604, U189783117, U176608402, US63277702, USM4840903, US29081203, USM18301, USN4644002, U80004501, U159630008, USM4212606, U236072901, US4484804, US70837703, US94752261, US94752334, US94752590, 2140532U01, 110910U040, 110636U006, 801954U004, 139946U016, 4561426U01, 145228U010, 121221U007, 6491323U01, 4843462U01, 110173U017, 110783U033, 149682U002, 148035U007, 148035U006, 1738060U02, 803274U003, 2426437U01, 2208430U02, 110513U032, 3534055U01, 1924556U14, 149033U007, 145133U010, 1695829U10, 1078247U06, 101829U003, 143288U003, 100371U012, 2204991U02, 100371U011, 109881U006, 100009U013, 112014U008, 104132U008, 2266273U01, 119882U004, 139931U031, 802714U006, 2321817U01, 109529U066, 145884U004, 110047U011, 117675U003, 110810U009, 6113585U01, 110055U007, 4565911U01, 389839U002, 4205247U01, 106989U033, 100018U017, 802786U100, 2002142U02, 100019U025, 2569214U03, 1020149U04, 1528754U02, 109970U013, 4812644U01, 112099U006, 6032292U03, 112099U005, 112099U007, 6032292U04, 120158U013, 110305U031, 120019U020, 800163U003, 1607646U04, 1607646U05, 104089U009, 104025U001, 142470U020, 3344113U13, 122008U013, 145684U006, 110143U009, 2249243U02, 142541U049, 109734U002, 2416273U01, 146221U006, 1305892U04, 1305892U05, 146584U002, 145771U027, 1496753U03, 150097U002, 2168118U01, 110939U009, 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2552578U01, 110235U010, 147583U003, 102529U003, H2080US31, H5724US01, VS63733VS6, HU1120US01, 083038201016212, 083038201024113, IE1068US15, B5128502, B5481110, A6096301, A5190707, A5209708, E5172904, A5348011, A5123662, A5422104, A5109319, UX9361, UXA286, UX9550, UX9547, UX9460, UX9566, UX9433, UX9399, UX9423, UX9356, UX9391, UX9523, UX9404, UX9369, UXA331, UX9401, UX9304, UX9187, UX9390, UX9548, UX9479, UXA168, UX9519, UX9466, UXA264, UX9392, UX9480, UX9297, UX9520, UX9343, UX9469, UX9350, UX9409, UX9503, UX9367, UX9478, UX9368, UX9353, UX9321, UX9452, UX9354, UX9549, UXA403, UX9436, UX9437, UX9461, UX9337, UX9565, UXB069, UX9513, UX9311, UXA341, UX9380, UXA237, UX9298, UX9336, UX9454, UX9340, UX9400, UXA346, UX9471, UX9285, UX9525, UX9363, UX9333, UXA242, UXA208, UX9517, UXA236, UXA340, UX9467, UX9545, UX9425, UXA330, UXA287, UX9508, UX9379, UX9258, UX9410, UXA312, UX9393, UXA259, UX9564, UX9070, UX9470, UXA329, UX9468, UX9316, UX9110, UX9115, UX9299, UX9422, UX9414, UX9567, UX9335, UX9362, UX9309, UXA342, UX9516, UX9518, UX9462, UX9421, 0850US7990, VS64017VS6, VS61967VS6, VS63031VS6, VS63131VS6, VS63345VS6, VS61969VS6, VS69324VS6, VS6CMV, DHG09402, GRN01427, STK0148, VS61792VS6, VS61489VS6, NO4015US25, NO4035US18, NO4088US30, NO4072US02, VS63896VS6, VS63875VS6, VS62395VS6, VS63893VS6, VS67001VS6, VS63005VS6, VS63524VS6, PL2085US02, PL0319US01, PL1862US02, PL2675US01, PL2837US01, PL2089US05, PL1025US01, PER34930, VS61710VS6, VS62094, VS63139VS6, RU1558US01, RU1558US02, RU1875US03, RU3776US01, RU6048US02, 6073UL0064, MP324909, O003US05, 502010US17, VS64482VS6, 00222ULT10, VS67006VS6, VS64491VS6); H45041DZ (140024US15, 190073US05, 220078US20, 030295US04, 100012US17, 747722US02, 550020US04, 030077US01, 060801US06, 030800US15, 030028US04, VS63948VS6, VS63912VS6, VS64001VS6, VS64069VS6, VS63821VS6, VS64081VS6, VS63940VS6, VS63004VS6, VS63956VS6, VS67325VS6, VS63749VS6, VS64059VS6, VS63819VS6, VS67945VS6, VS67738VS6, VS63801VS6, VS63817VS6, VS63829VS6, VS63788VS6, VS63711VS6, VS63812VS6, VS63784VS6, VS63832VS6, DK1561US01, DK1558US01, DK1008US01, DK1066US47, DK1314US06, DK1314US07, FI1307US02, HU1294US03, HU1389US01, IL4642US01, IL4129US01, C5124632, B5114288, A5261504, A5812268, A5812266, A205391201, A5812264, A5812273, D5803102, G5803102, A5404704, B5373007, A51152183, A51152176, 080087US05, VS60640VS6, VS62009VS6, NO4070US19, NO4018US20, NO4060US11, NO4198US10, NO4047US03, NO4005US69, NO4477US04, NO4068US58, NO4068US57, NO4068US68, NO4068US59, PL6599US02, PL6605US02, PL4739US03, PL6360US02, PL6804US03, PL6804US04, PL6804US02, SI4010US02, NE209949, DEN00723, YE643316, DEN00921, FEG37609, 437918US13, 260010US18, 569841US01, 00150ULT07, 00631ULT07, 20458ULT01, 00004ULT10, 00231ULT10, 20080ULT10, 01050ULT07, 00314ULT04, 00314ULT06, 00432ULT27, 00398ULT01); H45041FT (VS68885, VS64484, VS67567, VS61745, VS6MB7466, VS68883, VS68842, VS6MB003647, VS68810, VS67137, VS64103, VS6MB8656, VS6MB4573, VS68868, VS67821, VS65159, VS67392, VS67495, VS68050, VS68839, VS67872, VS65073, VS67892, VS68853, VS6R8268, VS68844, VS67854, VS67152, VS64202, VS67439, VS67296, VS67869, VS68806, VS6R774, VS64055, VS68090, VS6R0142, VS5R0718, VS68543, VS64146, VS6MB0791, VS67016, VS65180, VS67194, VS6R1998, VS6R2104, VS68858, VS67691, VS68275, VS68995, VS67855, VS68686, VS68308, AL4097US01, AL4104US01, BA4117US13, VS63947VS6, VS67629VS6, VS65189VS6, VS63961VS6, 604875VS6C, 604875VS6B, 403943VS6A, 403235VIV, 250737VS6, 905848VS6, 514747VS6, 705674VS6C, 416481VS6, 416340VS6, SN3976VS6, 8769VS6, CZ4012US37, CZ4047US11, CZ6323US10, DK1167US76, DK1167U114, DK1167U117, DK1047U141, USM4159709, U165309003, U123311602, U774132501, U553863901, U191824202, USM4548511, US55554118, 7487VS6, US29081314, USM9194401, U415804987, U415804978, U415804998, U415804984, U550684701, UN95957101, US26572603, U602013301, USS4440401, U489209001, US67238103, 3702VS6, US68233305, U502238501, US93011506, US88022321, U472797501, UMM4440401, U399665502, U226791503, U149087205, US26670008, 404420U712, 181034U113, 181034U240, 181034U188, 181034U149, 181034U211, 181034U119, 181034U179, 181034U081, 1810348U95, 1810348U96, 181034U120, 181034U148, 181034U028, 1810348U42, 181034U239, 210272U014, 210256U935, 210272U062, 210272U061, 210272U043, 210256U980, 105827U453, 1926829U05, 1926829U06, A106333808, A471376301, KO1148US01, 043066US01, PL6378US05, PL8034US01, ZA1025US22, ZA1025US21, A328US01); H45041FU (VS68990, VS68964, VS68538, VS67493, VS6MB2025, VS67121, VS67868, VS64157, VS67860, VS67075, VS64499, VS67117, VS6MB1992, VS64536, VS68721, VS6MB7673, VS68342, VS68274, VS68507, VS68884, VS64195, VS67199, VS68866, VS67848, VS67024, VS67877, VS68284, VS67611, VS68048, VS6289TEE, VS68387, VS68819, VS68762, VS68485, VS68673, VS67166, 604631VS6A, 905497VS6, 905602VS6, 416462VS6, 905547VS6, 250370VS6); H45041JW (0911363389); H45041PS (0911369283, 0911363838, 0911363968, 0911365672, 0911363939, 0911363943, 0911363952, 0911373547, 0911373548, 0911373609, 0911367296, 0911373617, 0911365792, 0911373564, 0911373594, 082438220047, 082438110060, 082438040210, 082438040209, 082438030082, 082438070140, 082438190055, 082438190057, 082438110069, 082438190054, 082438080064, 082438030106, 082438230090, 082438230105, 082438230106, 082438230114, 082438230111, 082438220045, 082438220046, 082438220056, 082438220049, 082438230112, 082438160246, 082438100220, 082438210107, 082438160304, 082438250047, 082438030113, 082438170037, 082438140134, 082438070169, 082438090215, 082438190050, 082438120395, 082438120432, 082438100229, 082437290214, 082438020042, 082438080043, 082438200028, 082438120454, 082438100240, 082438290059, 082438160219, 082438090265, 082438090234, 082437230588, 082438230093, 082438120414, 082437230587, 082438250048, 082438120415, 082438150070, 082438240012, 082438150061, 082438150086, 082438130088, 082438130092, 082438130097, 082438130098, 082438130105, 082438130106, 082438130107, 082438070144, 082438110054, 082438110087, 082438120397, 082438240011, 082438100207, 082438210089, 082438310088, 082438140110, 082438090209, 082438080047, 082438090247, 082438090268, 082438080046, 082438300021, 082438300024, 082438070109, 082438070127, 082438290060, 082438090287, 082438210090, 082438090210, 82438220053, 82438050045, 82438050048, 82438250058, U151072403, US94752361, US94752432, US94752597, US94752617, US94752631, 109045U027, 0828370363, 0828380232, 0828380263, 0828380266, 083038021046910, 083038200370112, 083038201018212, 083038281083815, 083038201170712, 083038601133311, 083038100058613, 083038281182512, 083038600312511, 083038600312512, 083038860516811, 083038600107913, 083038800150612, 083038201058511, 083038841134511, 083037005638413, 083037005638414, 083038001022411, 083038840108213, 083038860513611, 083038820007711, 083038001019612, 083038860154912, 083038801184112, 083038600002812, 083038020011811, 083038200058512, 083038807449113, 083038801094913, 083038801028512, 083038861061111, 083038800507312, UX9296, UXA447, UX9313, UX9381, UX9514, UX9413, UX9315, UX9382, UX9288, UX9441, UXA314, UX9322, UX9351, UX9295, UXA334, UX9412, UX9451, UX9435, UX9305, UX8011, UX9347, UX9506, UX9434, UX9355, UX9370, UXA240, UX9402, UXA438, UX9546, UX9515, UXA306, UX9507, UX9569, UX9453, UX9307, UX9352, 0850370021, 0920369469, 0920369539, 0843384100, PL1023US21, PL1023US22, PL0331US01, PL1777US02, PL2089US04, RU5734US01, RU6150US02, RU7214US01, RU3674US01, RU7367US01, RU7367US02, RU7368US01, RU7390US01, RU5488US03, RU3835US01, RU8618US01, RU3531US04, RU3836US01, RU1579US02, RU7877US01, RU7801US01, RU1461US02, RU1284US14, RU8267US01, RU1808US03, RU3851US01, RU3942US01, RU1047US08, RU2952US03, RU2952US06, RU7520US06, RU6484US03, RU5552US03, RU3257US04, RU1138US05, RU1382US03, RU3832US01, RU5455US02, RU7302US01, RU6048US03, RU6048US05, RU3593US04, RU5899US03, RU7365US02, RU1999US26, RU3843US01, 0847384177, 0847384439, 0847384442, 0847384456, 0856380222, 0856380226, 0856380231, 0856380247, 0856380254, 0856380255, 0856380207, 1648922002, 1647668482, 1647796242, 1890119046, 1647668602, 1706082462, 1601809375, 1890330112, 1648128832, 1889297662, 1878659932, 1566873842, 1650964522, 1647973382, 1844849302, 1592077982, 1509809174, 1796700592, 1648862082, 1648722512, 1648722516, 1634986662, 1560315461, 1515948463, 1525949672, 1642597652, 1582219582); H45041QG (VS68297, VS64072, VS68295, VS67043, VS68057, VS68937, VS67542, VS67863, VS65139, VS64475, VS67008, VS64524, VS67692, VS68110, VS64631, VS68843, VS6R8230, VS67573, VS68857, VS67771, VS6R0625, VS67674, VS62326, VS64129, VS68867, VS68850, VS68750, VS68892, VS6MB0482, VS68377, AL4101US01, AL4043US03, AL4032US01, AO1015US07, AP7830US01, AH0305US22, AP2305US03, AP8600US01, AP0790US01, AH4983US08, AH4001US70, AP6796US01, AH1301US05, AP5094US04, AH4323US80, AH1915US08, AP7489US01, AP5213US03, AH0132US42, AH0132US47, AP7094US01, AP0394US03, AP6285US02, AH2310US18, AH7157US02, AP6502US02, AH5090US07, AH5090US08, AP4515US03, AH5689US33, AH0101U101, AH4660US38, AP6056US02, AH0101U104, AP8439US01, 391885US02, AP8805US01, AP6557US02, AP8381US01, AH0101U105, AP8332US04, AH5848US76, AP7103US03, AH4316US09, AH4316US10, AP7147US03, AH0101U103, AH5848US77, AP6498US02, AH5848US80, AH0101U108, AP8708US04, AP5097US04, AP9017US01, 110069US03, 220176US01, 090070US17, 190059US16, 030020US18, 030082US18, 030082US17, 190190US13, 010120US23, 210001US35, 110065US38, 220913US02, 110040US13, 563899US01, 210002US62, 210002US63, 190747US16, 210013US20, 928880US01, 190747US18, 180043US08, 491838US04, 110901US12, 030032US03, 030032US02, 110094US20, 110094US16, 190145US14, 190171US12, 130015US04, BA4080US28, BA4068US03, BA4080US22, BA4209US01, BA4210US01, BA4211US01, BA4208US01, BG4521US02

Distribution pattern

device · product 3 of 8

Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0754-2023

Recall number: Z-0754-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 1,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

No US Distribution. Model Number (System ID): H45551WC (VS50226, VS5226, VS50038, VS593, VS5R34, VS50101, VS515, VS50086, VS5302, VS50040, VS50001, VS5251, VS50109, VS5R17, AF1025US01, DZ1318US01, DZ2655US02, DZ1312US01, DZ1291US01, DZ1282US01, DZ1316US01, DZ3071US03, DZ1310US01, DZ1330US01, VS50470VS5, VS50515VS5, VS50847VS5, VS50507VS5, VS5472VS5, VS5453VS5, VS50485VS5, VS50152VS5, VS57140VS5, VS50561VS5, VS50520VS5, VS50517VS5, VS50766VS5, VS5512VS5, VS50026, BG4549US18, CM1073US01, CZ6731US01, CZ6289US02, EG6217US02, EG5403US01, EG5446US01, EG5401US01, EG5399US01, EG5416US01, EG5457US01, EG5478US01, EG5152US04, EG5001US09, EG5479US01, EG5465US01, EG5480US01, EG1387US02, EG5477US01, EG5560US02, EG5665US01, EG5152US03, EG5481US01, EG5533US01, EG5430US01, EG5240US02, EG5428US01, EG7219US01, EG5468US01, EG5492US01, EG5649US01, EG5650US01, EG5452US01, EG5463US01, EG5396US01, EG5407US01, EG5279US02, EG5484US01, EG5394US01, UN04440402, GP1038US2, U204644801, U651447301, 5175276U01, 2077808U01, 2829800U02, 804380U002, H1987US03, H4954US01, H4930US01, H1371US08, H1093US23, H1640US02, H1819US02, H4955US01, H4931US01, 083037605299429, 083038605200639, 083038602001911, 083038602001912, 083038605200049, 083038609194410, 0835384070, 0835384071, 0835384880, IQ1297US01, A5267831, A6140801, A5674402, DF9010, UX9504, DFA003, DFA004, DFA006, JO1116US02, JO1113US02, 0850US5570, 0850US5734, 0850US5689, 0850US5984, 0850US5828, 0850US5914, LB1122US03, LB1000US03, LB1042US03, LY1089US01, 0834384051, 0834384052, 0834384053, 0834384065, 0834384066, 0834384069, MA1448US01, MA1421US01, MA1451US01, MA1326US02, MA1412US01, MA1429US01, MA1424US01, MA1433US01, MA1242US03, MA1434US01, PK1362US01, PK1331US03, PK1331US01, PK1331US02, PK1300US07, PK1297US01, PK1297US02, PK1322US01, PK1035US08, 0843384080, PL8489US01, PL0179US02, PPS20600, PPR79801, SA2330US13, SA2037US10, SA2330US12, SA2111US03, SA2139US03, SA2193US01, SA2215US01, SA1105US01, 0847384065, 0847384066, 0847384067, 0847384440, ZA1850US01, ZA1025US05, 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Distribution pattern

device · product 4 of 8

Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0755-2023

Recall number: Z-0755-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 708 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

No US Distribution. Model Number (System ID): H45551WB (VS6500, VS6440, VS60642, VS60584, VS6176, VS6495, VS6491, VS6396, VS6230, VS6MB0222, VS60208, VS698, DZ2175US02, DZ1343US01, DZ2174US01, 911367260, 030070US04, BW6007US01, VS63016VS6, VS60286VS6, VS62394VS6, VS63516VS6, VS60256VS6, VS63523VS6, VS60317VS6, VS62266VS6, V2085AD, BG4042US02, 905577VS6A, 905566VS6, 514843AVS6A, 604520VS6A, 705743VS6, 416431VS6, 416920VS6, 416665VS6, 416233VS6, 519890VS6, 519739VS6A, VS63924VS6, VS64507VS6, EG5631US01, FI1010US06, U421740701, US26664720, US60509705, USN4186702, US20768611, U160416403, U260793002, 149431U005, 2117508U01, 2216997U02, 1040088U02, 140580U003, 149430U001, 800158U006, HU1015US11, A5812265, 0850US5619, 0850US5979, LT4071US01, MA1465US01, NMG02410, RTD0947, NO4438US01, PL2303US02, PL1006US05, PL7001US01, VS64237VS6, F001US03, 16003ULT13, 21002ULT06, 21016ULT10, 34091ULT06, 34300ULT01, P34679UL06, P35027UL02, P16069UL01, 00478ULT07, 00023ULT52, VS64416VS6); H45561FF (0911369242, 0911366963, 0911366964, 0911366978, 0911367042, 0911365460, VS60324VS6, VS62263VS6, VS63533VS6, VS63192VS6, VS600340VS6, U315152207, 083038608111818, 083038607247313, 0835384074, 0850US7081, 0920369371, NG1206US01, 0847374821); H45561HF (5559, VS61850, VS61285, VS61576, VS60291, VS61421, VS6R0010, VS60062, VS61093, VS61094, VS61221, DZ1541US01, DZ1177US03, DZ1491US01, DZ1050US06, DZ1050US05, DZ1358US02, DZ1512US01, DZ1009US22, DZ1494US01, DZ1133US03, DZ1187US02, DZ1459US02, DZ1269US03, DZ1489US01, DZ1529US01, DZ1278US02, DZ1668US01, DZ1435US01, DZ1469US01, DZ1513US01, DZ1356US01, DZ1415US01, AZ4015US01, BH1056US08, VS63462VS6, VS61135VS6, VS64618VS6, VS62372VS6, VS61407VS6, VS63953VS6, VS63351VS6, VS62397VS6, VS63227VS6, VS63328VS6, VS63069VS6, VS62393VS6, VS61353VS6, VS62392VS6, VS6312VS6, VS62246VS6, VS63049VS6, VS6293VS6, VS63104VS6, VS62251VS6, VS62059VS6, 519740VS6A, 418525VS6A, 519250VS6A, VS62048VS6, 2018VS6, VS61705VS6, VS63411VS6, VS61951VS6, VS62021VS6, VS62092VS6, VS63001VS6, VS63359VS6, VS63271VS6, VS63865VS6, CZ4115US02, CZ6323US09, VS63169VS6, VS62360VS6, EG5316US09, EG5316US07, EG1418US07, EG5271US04, EG1592US05, 6044328U03, 118983U002, 103301U829, 103301U602, GH5036US02, GH5014US01, H5829US03, 083038602002811, 083038602004111, 083038602005911, 083038602006011, 083038602006111, 083038602006512, 083038602004211, 0835384093, 0835384094, 0835384100, 0835384101, 0835384105, 0835384111, 0835384118, 0835385936, IQ1341US01, IQ1278US02, IE1068US09, A5117912, B5114295, A5141214, A5517807, A5517811, JO4092US02, JO4000US12, JO1141US04, KW1010US05, KW1100US03, KW1114US01, LB1366US01, LB1055US02, LB1337US02, LB1249US02, LB1401US02, VS62253VS6, VS62264VS6, MA1493US02, MA1364US02, MA1482US02, VS64222VS6, NG1171US08, NG4111US01, NG1111US01, NG1097US03, NO4622US01, NO4001US03, NO4035US16, PK1035US14, PK1317US04, PK1201US03, PK1035US12, VS63003VS6, VS63692VS6, PL8364US01, PPR07117, VS63530VS6, RU2771US01, SA2332US01, SA1208US11, SA1208US06, SA1208US10, SA1333US01, SA1255US05, SA2137US06, SA1249US16, SA1056US44, SA2000US05, 0847384175, ZA2321US01, ZA2436US01, ZA2375US01, ZA2493US01, ZA1030US08, MPX56902, E003US07, 0853380206, 0853380253, 0853380268, 0853380278, 0853380302, 06098ULT03, P06104UL05, P06030UL14, E06001UL07, 07010ULT02, P07050UL03, 07021ULT03, P34151UL18, P10027UL02, 14002ULT11, 16032ULT09, 20007ULT04, 21002ULT16, 25001ULT12, 26011ULT05, 34362ULT04, P34500UL10, 34379ULT04, 34324ULT01, 34208ULT18, 34118ULT38, 34361ULT12, 34118ULT42, 34118ULT37, 34208ULT06, P34687UL16, 34361ULT02, 34361ULT03, 34300ULT10, 34300ULT03, 34297ULT01, 34382ULT01, 35049ULT06, P42012UL08, P42012UL07, 45001ULT08, P38003UL13, P63001UL25, P65021UL04, AE1395US01, AE1410US01, AE1015US18, AE1357US01, AE1408US02, VS63491VS6, VS62321VS6, VS63180VS6, YE1105US02); H45571SB (DZ2435US01, DZ1133US05, DZ1250US06, DZ1907US01, DZ2144US01, DZ2142US01, DZ2163US01, DZ1209US02, DZ1499US02, DZ1250US07, DZ1886US01, DZ1974US01, DZ1006US09, DZ1790US01, DZ1827US01, DZ1855US01, DZ1250US08, DZ2147US01, DZ2540US01, DZ1807US01, DZ2036US01, DZ1763US01, DZ1982US01, DZ1155US03, DZ1911US01, DZ1633US01, DZ1887US01, DZ2181US01, DZ1701US01, DZ1786US01, DZ1400US07, DZ1396US02, DZ2038US01, DZ1881US01, DZ1836US01, DZ1730US01, DZ1946US01, DZ1938US01, DZ1700US01, DZ1986US01, DZ3174US01, DZ1678US02, DZ1919US01, DZ2146US01, DZ1983US01, DZ1678US03, DZ2070US01, DZ1920US01, DZ2070US02, DZ1192US04, DZ1602US01, DZ1496US02, DZ2065US01, DZ2075US01, DZ1848US01, DZ1419US02, DZ1061US04, DZ1831US01, DZ1398US01, DZ4148US04, DZ1888US01, DZ1149US06, DZ1149US03, DZ1592US04, DZ1669US01, DZ1978US01, DZ1597US01, DZ1584US01, DZ1729US01, DZ1771US03, DZ1732US01, DZ2035US01, DZ1731US01, DZ1068US02, DZ1716US01, DZ1885US01, DZ1943US01, DZ2037US01, DZ1965US01, DZ1929US01, DZ2159US01, DZ1783US01, DZ1833US01, DZ1832US01, DZ2088US01, DZ1587US01, DZ2012US01, DZ2084US01, DZ1924US01, DZ1581US01, DZ1691US01, DZ2082US01, DZ1806US01, DZ1909US01, DZ1765US01, DZ3398US02, DZ2143US02, DZ2143US01, DZ1717US02, DZ1237US04, DZ1237US05, DZ2145US01, DZ1698US01, DZ1828US01, DZ1534US07, DZ1534US06, DZ1534US05, DZ1699US02, DZ2219US01, DZ1632US01, DZ2087US06, DZ2169US01, CI1006US05, EG1361US04, EG5784US05, EG6074US03, EG6591US03, EG7271US01, EG5271US07, EG5143US09, EG5174US14, EG1653US07, EG5174US13, EG6780US01, EG5794US04, EG7064US02, EG5988US01, EG5478US02, EG5998US03, EG6589US01, EG6000US02, EG5143US08, EG1422US07, EG5174US10, EG7274US01, EG6167US02, EG6721US01, EG6843US01, EG5983US02, EG6191US02, EG5791US04, EG6571US01, EG6846US01, EG7792US01, EG7277US01, EG6708US01, EG1001US03, EG5554US04, EG5876US03, EG6560US03, EG6658US01, EG6558US01, EG6054US02, EG6918US03, EG6605US01, EG5128US06, EG5602US02, EG7275US01, EG6882US01, EG6771US01, EG7239US01, EG5396US02, EG7234US01, EG5963US04, EG5823US03, EG6406US09, EG1599US03, EG1599US04, EG5606US04, ET1026US01, 083033821079213, 083038609664314, 083038200024717, 083038602144917, 083038602955616, 083038602988116, 083038609894616, 083038609914416, 083038602798413, 5512UL0340, 5512UL0257, 5512UL0703, 5512UL0781, 5512UL0704, 5512UL0792, 5512UL0354, 5512UL0579, 5512UL0901, 5512UL1242, 5512UL0902, 5512UL0733, 5512UL0907, 5512UL0732, 5512UL0906, 5512UL0734, 5512UL0842, 5512UL0351, 5512UL0793, 5512UL0305, 5512UL0300, 5512UL1052, 0835385954, 0835385960, 0835385970, 5512UL0573, 5512UL0578, 5512UL0484, 5512UL1036, 5512UL0796, 5512UL0822, 5512UL0642, 5512UL1017, 5512UL0577, 5512UL0761, 5512UL0580, 5512UL0181, 5512UL0370, 5512UL0644, 5512UL0486, 5512UL0735, 5512UL0304, 5512UL0258, 5512UL0339, 5512UL1008, 5512UL1344, 5512UL0371, 5512UL0419, 5512UL0417, 5512UL0407, 5512UL0372, 5512UL0576, 5512UL0254, 5512UL0815, 5512UL0418, 5512UL0485, 5512UL0643, 5512UL0905, IQ1271US03, IQ1396US01, IQ1546US01, IQ1796US12, IQ1796US11, IQ1266US08, IQ1266US09, JO4115US03, JO4000US10, JO1141US08, JO4041US02, JO1074US04, JO4114US03, KW1008US18, KW1095US04, KW1011US28, KW1039US05, KW1134US01, KW1020US13, KT1083US01, LB1000US12, LY1067US02, LY1143US01, MA1274US03, MA1422US02, MA1268US02, MA1190US04, MA1422US03, MA1200US01, MA1400US15, MA1400US13, MA1400US14, MA1420US03, MA1255US04, MA1255US06, MA1013US20, MA1255US05, MA1272US21, MA1272US23, MA1272US22, MA1536US01, GRN01437, NG1159US02, NG1127US03, PK1446US02, PK1429US02, PK1404US01, PK1003US05, PK1458US02, PK1360US02, PK1430US01, PK1413US02, PK1371US01, PK1317US12, PK1035US24, PL8177US03, QA1074US01, SA2050US04, SA1060US12, SA1216US16, SA1216US19, SA2120US01, SA2503US01, SA1004US14, SA1382US03, SA2267US01, SA2478US02, SA1176US10, SA2485US03, SA2191US20, SA2271US01, SA2268US02, ZA2317US02, ZA2685US02, ZA1030US15, ZA2812US06, ZA2812US05, ZA2812US09, ZA2126US01, ZA2685US03, ZA1090US09, ZA2668US01, 01036ULT10, 03002ULT05, P02017UL05, P06043UL11, E06001UL08, P06020UL05, P06219UL01, P72012UL06, P72008UL07, P16080UL01, 59025ULT01, 25001ULT19, P25016UL28, 25001ULT18, 26023ULT02, 27005ULT17, P27009UL06, 34373ULT08, P34588UL05, 34217ULT01, 34373ULT11, 34373ULT22, 34254ULT06, P34440UL06, 34287ULT14, 34373ULT21, 34118ULT46, 34317ULT08, 34091ULT19, 34373ULT10, 34118ULT47, 34365ULT04, 34373ULT09, 34126ULT11, P34460UL05, 34435ULT04, P34589UL01, 34382ULT21, 34382ULT23, 34803ULT01, P41031UL09, 36003ULT07, 41009ULT15, P44030UL25, 33043ULT34, 33043ULT38, 33043ULT40, 33043ULT36, 33043ULT35, 33043ULT37, 33043ULT39, 33043ULT22, 33043ULT23, 33043ULT31, 33043ULT33, 33043ULT32, DZ2083US01, 59019ULT05, P63001UL15, P63001UL14, AE1387US05, AE1100US04, AE1387US03, AE1100US06, AE1600US12, AE1023US04, AE1126US16, AE1209US01, AE1604US06, AE1433US03, AE1488US09, AE1477US03, AE1367US02, AE1015US44)

Distribution pattern

device · product 5 of 8

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0756-2023

Recall number: Z-0756-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 7,931 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

Model Number (System ID): H45021A (VI4552, VI351); H45021AF (VI1246, VI327, VI1415, VI256, VI00887, VI1119, VI000832, VI0468, VI666, VI1658, VI1263, VI1676, VI1673, VI1261, VI689, VI921, VI1148, VI511, VI050852, VI1295, VI1166, VI1247, VI1536, VI730, VIMB00435, VI431, VI2397, VI1029, VI554, VI1020, VI0658, VI1432, VI51073, VI880, VI1199, VI994, AVHSE20751, VI311, VI379, VI1256, VI1214, VI345, VI193, VI336, VI1097, VI853, VI1488, VI848, VI1017, VI739, VI1258, VI248, VI732, VI148, VI1410, VI1234, VI697, VIR55546, VI153, VI562, EPSW59BF, VI1452, VI669, VI342, VI1118, VI1259, VI1529, VI1394, VI055240, VI963, VI651, VI1437, VI1517, VI50194, VI257, VI824, VI621, VI622, 393204, VI623, VI0579, VI1446, VI1552, VI374, VI906, VI1241, VI132, VI797, VI907, VI1236, VI1565, VI638, 912535VIVID, VI1321, VI526, VI258, VI261, VI50588, VI303, VI000459, VI000228, VI914, VI055696, VI1600, VI816, VI896, VI684, VIV0704, VI1240, VI365, VI358, VI653, VI230, VI680, VI480, VIMB000788, VI1205, VI1531, VI949, VI1284, VI282, VI660, VI463, VI643, VI551, VI113, VI573, VI1363, VI2306, VI538, VI208, VI1506, VI1509, VI1508, VI1507, VI711, VIV1530, VI0696, VI1451, VI654, VI1154, VI1698, VI1279, VI456, VI457, VI808, VI905, VI1233, VI692, VI1435, VI417, VI2495, VI927, VI1397, VI1558, VI986, VI1858, VI1596, VI1235, VI277, VIR00196, VI170, VI471, VI1571, VI21206, VI670, VI215, VI945, VI0789LO, VI841, VI348, VI1684, VI1030, VI1367, VI312, VI1539, VI838, VI1212, VI281, VI619, VI620, VI655, VI703, VI1265, VI1301, VI1472, VI912, VI1418, VI1442, VI1473, VI1395, VI834, VI253, VI279, VI394, VIR709, VI275, VI243, VI856, VI1156, VI1484, VI408, VI1456, VI1317, VI1232, VI1302, VI1389, VI724, VI630, VI1886, VI542, VI893, VI395, VIMB000294, VI883, VI1616, VI1449, VI302, VI567, VI2289, VI1244, VI1299, VI1444, VI671, VI989, VI332, VI001207, VI672, VI1337, VI1492, VI247, VIR912, VI1142, VI274, VI1252, VIV869, VI00299, VI1784, VI782, VI748, VI1310, VI2313, VI1288, VI286, VI1218, VI768, VI414, VI0344, VI1290, VI922, VI575, VI1357, VI936, VI937, VI154, VI373, VI604, VI50886, VI5081, VI961, VI894, DSVI900, VI899, VI00234, VI1443, VI400, VI000774, VI1164, VI176, VI1204, VI201, VI940, VI437, VI124, VI977, VI284, VI384, VI387, VI521, VI20837, VI810, VI616, VI385, VI667, VI1283, VI998, VI747, VI237, VI533, VI001910, VI360, VI425, VI683, VI235, VI1445, VI996, VI56237, VI909, VI910, VI472, KIB02315, 0911365015, 0911366801, 0911367091, 0911363072, 0911363595, 0911362998, 0911363613, 0911365507, AH0132US17, AH5406US01, AH5406US06, AH0210US01, AH5846US19, AH0101US40, AH1908US12, AH5528US01, 242393VIVIDI, BY4015US07, BY4015US06, 497634US01, 130083US07, 220078US18, 508062US01, 110065US13, 070050US03, 270045US01, 220149US02, VI4300VI, VI4268VI, VI56349VI, VI220, VI56664VI, VI56763VI, VI20790VI, VI4701VI, VI4368VI, VI4200VI, VI004352VI, VI030617VI, VI004380VI, 705728VIVIC, 902564VIVI, 905634VIVIDI, 403835US1, 519623VI1, 905279VIVI, 905848VIVIC, 905848VIVIA, 905306VIVI, 905848VIVIB, 905615VIVI, 514842AVIVIDI, 514376VIVI, 514376VIVI2, 705658VIVIA, 604520VIVIDI, 819764VIVID1, 416543VIVI, 416755VIVI1, 905937VIVI, 905881VIVI, 416586VIVI, 604875CVIVI, VI20213VI, VI20548VI, 082438040068, 082438040103, 082438230020, 082438130037, 82438210030, 2606197VIVID, VI20598VI, CZ4164US04, CZ4148US02, CZ4010US02, DK1083US16, DK1083US20, DK1047US24, DK1007US05, DK1406US01, DK1030US18, DK1018US07, DK1077US04, DK1106US03, DK1042US11, DK1042US10, DK1059US04, EE4029US04, EE4020US10, FI1026US02, FI1029US04, FI1231US01, FI1244US01, FI1177US01, FI1015US11, FI1015US09, FI1258US01, FI1017US08, FI1052US06, SCIL046401, USM1524105, U460234401, USM4172604, US62664102, U409665101, U136818203, U233095102, U344924901, U203807002, U203807003, USM2311803, U240676905, USM4216602, U195212857, 110910U029, 110910U022, 110984U004, 110387U007, 110913U001, 145740U003, 117250U007, 110783U020, 110783U021, 149157U006, 1282953U01, 138808U018, 110012U021, 1286663U02, 1474472U01, 138809U008, 1519440U01, 142464U006, 110052U015, 138865U012, 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1767561U06, 145424U018, 2194478U03, 1767561U05, 145424U017, 145424U035, 138808U030, 105846U002, 110513U006, 1767561U17, 1293950U12, 1879404U01, 110458U005, 110458U007, 1078247U02, 110009U005, 138403U002, 111007U017, 123003U010, 1288556U02, 803983U006, 120008U015, 138809U009, 138809U010, 103135U016, 103135U015, 103135U013, 145871U004, 100007U010, 1858042U01, 4784893U01, 1987234U01, 145878U012, 122024U023, 122024U014, 122024U015, 122024U016, 120111U017, 1799734U01, 109529U056, 109529U063, 110047U007, 110046U010, 113023U040, 1765614U01, 1935372U01, 122016U019, 122016U018, 148004U005, 138865U016, 138865U017, 138865U015, 138865U018, 106989U018, 147079U003, 106989U015, 100540U008, 109970U008, 100019U012, 112307U013, 112307U012, 112307U016, 104100U004, 1882626U02, 1607646U03, 210502U005, 1284678U03, 122006U044, 122006U015, 122006U013, 145326U006, 108221U010, 122033U022, 110419U010, 110565U004, 1191717U07, 109634U012, 110549U001, 800972U003, 120026U002, 3400935U03, 149615U006, 142541U031, 142541U064, 122109U024, 142541U030, 142541U035, 120139U023, 1685347U02, 2032894U01, 112037U034, 112037U032, 210096U004, 210096U003, 145070U007, 118122U004, 120122U016, 141849U001, 1871656U01, 145771U018, 145771U014, 145771U017, 148066U004, 145771U016, 110289U003, 120063U009, 1789103U01, 2451669U01, 150735U004, 149657U016, 110773U006, 142453U020, 104039U017, 104039U021, 110526U006, 110408U007, 138348U014, 138348U013, 110477U009, 120035U008, 138907U009, 149843U003, 110112U008, 109834U005, 110690U003, 145776U009, 103013U010, 149707U010, 110247U007, 138260U003, 138607U005, 110826U001, 800529U003, 112132U002, 5198462U03, 117027U013, 112191U022, 1702078U01, 109673U007, 389961U097, 1750612U01, 110128U010, 120050U053, 120050U054, 109725U005, 109725U004, 145131U008, 1701614U02, 2667512U01, 124993U004, 1715002U01, 120054U006, 800830U194, H1353US05, H1043US12, H1277US16, H2008US21, H4535US01, H2077US30, H6886US01, H1404US16, H1383US13, H1383US17, H1093US19, H2017US09, H1420US13, H2063US05, HU1094US07, HU1094US04, HU1255US04, HU1255US07, HU1111US02, HU1042US03, IS1009US01, 083038825100967, 083038825103137, 083038827851037, 083038825103187, 083038805007438, 083038000101588, 083038845104338, 083038825000436, 083038805100358, 083038205104457, 083038205004348, 083038205104287, 083038865101058, 083038205102009, 083038005104617, 083038025103638, 083038867473968, 083038029010098, 0835384040, IE1007US03, IE1043US07, IE1005US02, IE1136US01, IE1136US03, IE1015US11, IE1018US08, IE1018US09, IE1122US01, IE1193US01, IE1132US01, IE1053US05, IL4246US07, IL4027US05, IL4746US33, IL4776US01, IL4270US21, IL4710US13, IL4263US21, IL4764US51, IL4758US26, IL4018US01, IL4014US21, IL4414US01, A5220715, D5104326, A175839801, C5103511, A5360456, A5360457, A5360458, A5360459, A200060701, A184083205, B5368903, A5107765, B5810910, A175992601, A5251122, B5124504, A5300609, A5374103, B5342718, A5221711, A5810821, A5303329, A5207210, A5374309, A5813605, A6099301, A5996101, A5352205, A5103008, A51125119, A5645316, E5367801, A5624118, A141169501, A5624120, A141169505, A5129975, A5944402, A5263008, A5316825, C5316825, B5820886, A5529117, B5374218, A6358001, A5991501, A5111247, A5272511, C5808613, A51142114, A5996301, A6048801, A5618375, A5618372, A5333065, B5129909, B5115226, A179434801, A5183645, A5993201, A5103521, A5347105, A5177367, A5824305, A5196508, A145688229, B5120725, B5120727, B5120724, A5101469, B5101421, A5101467, A5101468, B5111129, B5111125, A5358635, A5956202, A5806208, VI3930VI, KA1000US04, KA2738US05, KA2848US01, KA4039US01, KA2768US04, KA2857US01, KA4004US01, KA3080US03, KA1048US02, KA1028US02, KA3104US01, KA1060US03, KA2748US02, KA4116US01, KA4127US01, 0850US4848, 0850US5320, 0850US5321, 0850US5814, 0850US5062, 0850US5571, 0850US5104, 0850US4847, 0850US4769, 0850US5026, 0850US4658, 0850US4733, 0850US4844, 0850US5090, 0850US5556, 0850US5245, KW1055US02, LT4000US24, 080017US04, 200012US03, 815992US03, VI4339VI, VI30109VI, VI4444VI, VI009995VI, VI21286VI, VI79385WX1, VI003949VI, VI003983VI, 2649965, VI004046VI, VI004439VI, VI004032VI, VI3836VI, VI3943VI, VI3975VI, VI003836VI, VI30100VI, VI2867VI, VI3992VI, VI2814VI, VI4340VI, VI30128VI, VI21504VI, VI030153VI, VI4032VI, VI4336VI, VI4077VI, VI004455VI, VI30091VI, VI2873VI, VI4440VI, VI4451VI, VI3922VI, VI4017VI, VI004431VI, VI4431VI, VI4439VI, VI3923VI, VI21509VI, VI4363VI, VI2841VI, VI4123VI, VI4040VI, VE84908SU3, VI4083VI, VI30163VI, MZ0005US01, ALK0141, AMV0140, AMS2943, AMS1052, AMS1045, APL0141, APL0142, DLF0240, DHG0545, EDE0144, ENS0152, HGL0243, HDD0540, LDD0443, LLS0143, MDL0141, RTD1440, RTD0243, RTD09403, RTD0247, SCD0141, SLD0140, SNK0143, SPK0240, TLB0347, TLB0540, UDN0141, UTR0145, UTR0144, VRS0243, WIN0145, WRD0141, HGV0240, 85212930569, NO4054US19, NO4028US11, NO4077US12, NO4144US03, NO4029US09, NO4095US03, NO4051US07, NO4014US12, NO4041US05, NO4041US02, NO4016US66, NO4016US34, NO4037US31, NO4022US04, NO4035US24, NO4148US03, NO4088US15, NO4179US09, NO4179US21, NO4179US47, NO4179US17, NO4179US20, NO4179US12, NO4179US13, NO4180US05, NO4179US05, NO4179US24, NO4179US19, NO4179US11, NO4179US06, NO4179US08, NO4179US33, NO4149US05, NO4179US26, NO4179US25, NO4149US06, NO4179US44, NO4180US06, NO4179US22, NO4179US30, NO4179US27, NO4179US31, NO4179US04, NO4179US14, NO4179US07, NO4179US10, NO4179US46, NO4179US48, NO4179US23, NO4179US02, NO4179US45, NO4179US15, NO4179US32, NO4179US16, VI3294VI, VI50398VI, VI2614VI, VI2175, VI30434VI, VI30311VI, VI2704VI, VI3610VI, 0843384053, 843384062, 843384077, PL2496US01, PL1838US02, PL6691US02, PL4019US02, PL6498US01, PL1696US01, PL0042US01, PL7073US01, 600040US04, PL1023US14, 600035US02, PL1577US03, PL7368US01, PL1602US18, PL6860US01, PL1027US06, PL1541US04, PL1930US01, PL2958US05, PL1607US02, PL2070US01, PL1896US01, PL7112US01, PL6488US02, PL4359US04, PL7428US01, PL1232US02, PL2311US01, PL1843US02, PL4631US05, PL1042US05, PL1006US04, PL1006US20, PL7176US01, PL6682US01, PER43231, PER18419, PER18306, PER03512, PPR54401, PER28511, PPR23719, PPR49706, PER18135, PPR97301, PER01507, PPR98709, PER06631, PPR36120, PER05606, PPR60903, VI3729VI, VI2271, VI3752VI, VI3752V_W, VI4846VI, VI21157VI, VI2896VI, VI3837VI, VI4039VI, VI20745VI, RO4074US06, RO4214US01, RO4234US02, RO4254US02, RO4601US01, RO4183US02, RO4651US01, RU2269US03, RU1015US05, RU1556US15, RU1556US16, RU1556US27, RU1980US08, RU1516US07, 600130US14, RU1105US02, RU1295US19, RU1479US05, RU1092US06, RU1105US15, RU1591US17, RU1018US10, RU1018US11, RU0274US01, RU1830US10, RU1048US06, RU3468US10, RU2741US04, RU6170US02, RU2741US07, RU2741US02, RU2741US03, RU1139US04, RU2741US01, RU2741US37, RU2741US38, RU9796US01, 600105US07, 600105US09, RU4489US03, RU6396US03, RU1999US04, YU4060US04, YU4184US01, 0847384045, 0847384073, 0847384053, 0847384054, 0847384155, SK4072US03, SI4073US02, ZA2274US01, ZA2151US02, YP646802, NE465114, DEF11018, ME645941, ME208354, ME244382, MPX82223, ME244387, MPX50903, ME208355, ME244383, DE619849, FEC800111, FEC800127, ME504365, FEG46133, FEG32749, GEE34061, CE561228, DED64796, DPL32924, FEF70530, DEK78816, YE167224, MEX68990, FPG30526, DE669632, CEE15667, YE626928, UE255911, EE561705, SD1090US01, U008US01, W006US01, A004US22, D007US06, N001US06, O010US06, O005US15, O005U103, R002US14, S003US02, A111US10, E001US32, E008US04, E001US26, AC003US03, A008US01, Y004US06, A080US01, A044US12, A044US10, A044US17, A044US11, O027US02, 505100US03, 722050US03, 794150US07, 475050US04, 121383US03, 121512US09, 730050US03, 652040US03, 712786US01, 691302US01, 142017US02, 547090US05, 0856380093, 856380055, 0856380059, 0856380057, 0856380074, 0856380078, 0856380082, 0856380097, 0856380101, 0856380110, 0856380117, 0856380122, 0856380127, 0856380088, 0856380092, 0856380102, 0856380126, TT-2664087-US, TT-2691433-US, 34009UL15, 41009ULT05, P67002UL02, UK5025US01, UA4169US01, UA5101US01, IE1503US03, IE1504US01, IE1507US03, IE1504US02, IE1513US09, IE1510US08, IE1510US09, IE1508US02, IE1164US05, IE1509US01, IE1510US12, 00288ULT03, 00115ULT22, 00001ULT14, 00001ULT19, GB1278US01, 00681ULT17, 10102ULT09, 10044ULT05, 10044ULT07, 00666ULT07, GB1245US01, 21217ULT02, 00441ULT12, 00189ULT01, 00130ULT17, 00180ULT07, 00025ULT04, 00383ULT09, 00026ULT05, 00028ULT30, 11035ULT01, 10845ULT01, IE1169US01, 10192ULT03, 20041ULT02, 10913ULT02, 00137ULT03, 00506ULT07, 00259ULT05, GB1155US01, 05252ULT03, 00223ULT08, 00240ULT13, 00046ULT22, GB1223US01, 20449ULT01, 00488ULT04, VI3155VI, VI50140VI, VI050418VI, VI2891VI, VI050858VI, VI30557VI, VI30562VI, VI030567VI, VI030565VI, VI30568VI, VI30539VI, VI30564VI, VI30551VI, VI030559VI); H45021JL (VI1601, VI4688, VI4818, VI00877, VI20063, VIR0956, VIR172, VSIMB00691, V7MB8347, VI020215, VIR1949, V7MB7108, VSIMB00477, VSIMB00268, V7PMB8361, VSIMBB00199, VIR858, VIR1243, VIR737, VIR004873, V76097, VIR142, VIMB955, VIMB731, VIR461, VI00569, VIMB1499, VSIMB65, VSIMBB00180, VIR602, VIR001160, VI223, VIR000409, VIR238, VIR911, VI2498, VI1102, VIR2107, VIR2975, VIR980, VIR00241, VI2567, VIR1849, V7MB6876, VSIMB00331, VIMB2002, VSIMBB00164, VSIMB00121, VI20113, VI001294, VIR4002, V72104, VIR2081, VIMB002646, VI231, VI1556, VIR1677, VI4324, VIR003068, VI885, V7PMB6720, VIMB2484, VSIMBB00173, V7PMB6968, VSIMBB00259, V9MB3200, VIMB1326, V7MB8236, VIMB997, VIMB00308, VIMB2970, VI272, VIMB001748, VI4529, VSIMB01066, VI4271, VIVR175, VIR3484, VIR004997, VIMB002709, VI20186, VIR1789, VIR3735, VIMB003370VI, VIR3878, VIR2061, VIMB1287, VIR2311, VIR2424, VI5083, VIMB002992, VIR1163, VIR1034, V7MB6640, VIMB242, VSIMB01211, VIR1358, VIMB3570, VIMB003209, VI962, VIR3244, VI002172, VIR1879, VIR790, VI458, VI001018, VI4847, VI1810, VI1171, VSI00252, VIR2141, VIR2617, VI5052, VIR1593, VIR1666, VSIMB125, VIMB2437VI, VIMB002768, VIR4536, VIMB002474, VIR4907, 0911365271, 0911365384, 0911365399, 0911365508, 0911365489, 0911365225, 0911365274, 0911365469, 0911363371, 0911365426, 0911363432, 0911366839, 0911363777, 0911369204, 0911363242, 0911366890, 0911363296, 0911363452, 0911373826, 0911365444, 0911369146, 0911369181, 0911366860, 0911366899, 0911367237, 0911367071, 0911367072, 0911369177, 0911369178, 0911365430, 0911365450, VI20295VI, 905451VIVI, 647938VI1, 519842VIVI, VIR743, 905482VI6, 082438090138, 082438070070, 082438160143, 082438040077, 082438040093, 082438040094, 082438040112, 082438040116, 082438040119, 082438040127, 082438160122, 082438160126, 082438040102, 082438280010, 082438120361, 082438150040, 082438160113, 082438160134, 082438110046, 082438110050, 082438100131, 082438140083, 082438290017, 082438290030, 082438290037, 082438110038, 082438150049, 082438090129, 082438130051, 082438130054, 082438070072, 082438070086, 082438210051, 082438120333, 082438050021, 082438050019, 082438050027, 082438100114, 082438210037, 082438310042, 082438310036, 082438280008, 082438090121, 082438100135, 082438080024, 082438120357, 082438150045, 082438150046, 082438160137, VI004639VI, VI003813, VI004026VI, VI005084VI, VI004423VI, VI004667, CZ6100US02, 141326U171, 1861644U01, 106989U034, 105827U175, 1926826U34, 818670U335, 083038804997518, 083038605102007, 083038800161099, IE1110US03, 0850US5812, 0850US5558, 0850US5772, 0850370167, 0850US5751, 0850US4841, 0850US5227, 0850US5095, 0850US4768, 0850US4880, 0850US5011, 0850US5552, 0850US5135, 0850US4882, 0850US5083, 110807US07, 0920369372, 0920369385, 0920369311, 0920369381, 0920369393, 0920369355, 0920369315, PL0026US02, 0853380152, 0856380054, VI00376VI, 3882637107USSOR); H45021KC (VI55091, VI003556VI, VI003966VI, 0828380059, PER18204, RU2279US02, 0853380099, 0853380133, 0853380139, 0853380171, 0853380178, 0853380180, 0853380187, 0853380188, 0853380195, 0853380212, 0853380236, 0853380237, 0853380242, 0853380246, 0853380259, 0853380260, 0853380277, 0853380280, 0853380281, 0853380294, 0853380297, 0853380298, 0853380299, 0853380300, 0853380314, 0853380315, 0853380318, 0853380340, AE1131US01, IE1502US04); H45021WP (VI20901, VIR020658, VI20978, VI5067, VI5177, VI20860X, VI20721, VI20651, VIR020297, VI4587, VI21098, VIR20602, VI20262, VI20737, VI4902, VI3179, VI4868, VI21261, VI20589, VI020124, VIR4443, VIMB30611, VIMB20094, VI020209, VIMB30332, VI020116, VI20590, VI20057, VI20123, SHIUS404, VI20840, VI20089, VI20222, VI21076, VI20718, VI5155, VI2110, VI20967, VI020854, VI21057, VI021017, VI20391, VI20680, VI5064, VI20678, VIR20544, VI20542, VI4609, VI4885, VI5138, VI20685, VI20507, VI020114, VI4666, VI21016, VI21210, VI21052, VIR004074, VIR3416, VI20127, VI20039, VIR3417, VI4820, VI3433, VI20557, VI4623, VI20645, VI20647, VI20575, VIQ410002, VI20666, VI5101, VI20450, VIR000214, VI20538, VI20726, VI20497, VI20311, VI4918, VSIMB01147, VIR4569, VI20648, VI2672, VI020175, VI20504, VI20509, VI21066, VI20855, VI20993, VI20960, VI20

Distribution pattern

device · product 6 of 8

Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0757-2023

Recall number: Z-0757-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 2,609 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

Model Number (System ID): H45021WZ (VQ20056, VQ20718, VQ020015, VQ20399, VQ202400, VQ20127, VQ20529, VQ20505, VQ20502, VQ20533, VQ20741, VQ20683, VQ20653, VQ20700, VQ20580, VQ20477, VQ20498, VQ020516, VQ020216, VQ20507, VQ20772, VQ20686, VQ20043, VQ20508, VQ20566, VQ20620, VQ20525, VQ20483, VQ20601, VQ20706, VQ20591, VQ20122, VQ20668, VQ020275, VQ20713, VQ20198, VQ20863, VQ20052, VQ20597, VQ20619, VQ20614, VQ020676, VQ20154, VQ20584, VQ20599, VQ20204, VQ20429, VQ20284, VQ20045, VQ20568, VQ20562, VQ020662, VQ20524, VQ20730, VQ20628, VQ20287, VQ20266, VQ20569, VQ20110, VQ20116, VQ20109, VQ20560, VQ20671, VQ20278, VQR20075, VQ20504, VQ20607, VQ20007, VQ20054, VQ20611, VQR020000, VQ20910, VQ20133, VQ20108, VQ20415, VQ20469, VQ20367, VQ20341, VQ20051, 516663VIVIDQ, VQ20755, VQ30010LO, VQ20715, VQ020732, VQ020745, VQ20585, VQ20288, VQ20412, VI002091, VQ20712, VQ20702, VQ20464, VQ20417, VQ20638, VQ20722, VQ20747, VQ20593, VQ20456, VQ20326, VQ20181, VQ20773, VQ20522, VQ20081, VQ20521, 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N001US25, L005US02, M007US19, A111US09, A111US08, O020US06, O020US05, E001US89, E001US67, O010US12, O010US10, R002US50, R002US52, A007US55, A022US45, A010US66, A044US20, A022US56, P001US30, 363020US04, 547150US04, 529030US16, 103000US05, 547010US09, 262020US05, 501464US05, 547010US08, 529050US12, 913758US02, 913758US01, 756020US03, 795020US07, 122201US01, 652040US07, 225030US22, 529150US37, 252631US01, 482893US02, 0853380264, 0853380271, 0853380282, 0853380288, 0853380304, 0853380310, 0853380342, 0853380347, 0853380350, 0853380354, 0853380359, 0853380364, 0853380365, 0853380366, 0853380371, 0853380372, 0853380373, 0856380264, 0856380279, 0856380286, 0856380293, 0856380297, 0856380314, 0856380319, 1573UL0210, 0856380307, 0856380338, 0856380345, 1573UL0084, 1573UL0429, 1573UL0390, 99999ULT71, UA4338US03, UA4338US01, UA4338US02, UA4329US04, IE1566US10, 10010ULT17, IE1503US09, IE1511US11, IE1511US09, IE1504US10, IE1566US09, 00361ULT13, 21200ULT01, 00361ULT12, 05452ULT10, 05452ULT05, 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1961973872, 1961973892, GB1040US01, 00020ULT16, 21148ULT02, 21303ULT05, 00285ULT20, 00285ULT24, 00285ULT21, VQ56262VQ, VQ55178VQ, VQ55849VQ); H45041G (83110090682, 83112469417, 83114483855, 83129518957, 83130057214, 83130057281, 83145121565, 83164179701, VQ55483VQ, VQ56025VQ, VQ55480VQ, VQ20859VQ, VQ55667VQ, VQ55359VQ, VQ55739VQ, VQ55138VQ, VQ55198VQ, RU9241US03, RU6213US02, RU3636US02, RU8221US05, RU5081US02, RU7648US01, RU8618US02, RU3584US02, RU5894US02, RU3532US05, RU6551US06, RU6551US07, RU7175US07, RU7175US22, RU7175US24, RU7932US03, RU8299US03, RU8379US01, RU8673US01, RU6235US02, RU9405US01, RU3970US06, RU3798US02, RU8996US01, RU8314US01, RU8921US02, RU9235US01, RU3919US01, RU6396US06, RU5026US02, 0853380319, 0853380327, 0853380328, 0853380331, 00028ULT73, VQ055300VQ); H45041SX (83129185778)

Distribution pattern

device · product 7 of 8

Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0758-2023

Recall number: Z-0758-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 113 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

No US Distribution. Model Number H45561AC, System ID: DZ1237US02, AO1015US01, EG1843US01, EG5882US01, EG1621US04, EG1621US03, 2538978U01, 083038042857318, 083038602007811, 083038602826113, 0835384095, IQ1165US05, IQ1376US01, KE1049US01, KW1010US04, KW1102US04, KW1001US35, KW1011US21, KW1011US22, KW1006US14, KW1098US06, KW1020US15, KT1061US01, KT1062US02, LB1359US04, 1553UL1026, 0834380243, 0834384085, 0834384095, MA1251US13, MA1272US10, OM1042US03, OM1007US11, OM1007US12, PK1331US08, PK1331US06, PA1097US01, SA1201US02, SA1014US07, SA1337US05, SA1060US08, SA1147US05, SA1149US03, SA1051US09, SA2220US02, SA2220US01, SA2072US17, SA1028US06, SA1089US07, SA1138US05, SA2158US07, SA1340US02, SA1223US15, SA1002US08, SA1036US06, SA1025US03, SA2214US03, SA1272US10, SA1024US04, SA1101US04, SA1034US20, SA1249US11, SA1034US23, SA1058US60, SA1058US47, SA1058US59, SA1332US03, SA1030US05, SA1282US05, ZA2573US01, ZA2422US01, ZA2328US01, ZA2339US01, ZA2420US01, ZA1024US07, ZA2348US01, ZA2358US01, ZA1030US10, ZA2421US01, ZA1025US16, ZA1025US25, ZA2378US01, ZA2510US01, TN1028US04, 01002ULT25, 06004ULT19, 07021ULT02, P34189UL17, 21002ULT18, 23002ULT06, P23003UL12, 32004ULT18, 34013ULT13, 34037ULT16, 34013ULT14, P35076UL03, 38006ULT08, 42002ULT12, 42002ULT10, P50005UL02, 55001ULT13, 60001ULT07, P61029UL05, AE1283US01, AE1353US01, AE1016US16, AE1016US14, AE1016US15, AE1011US18, AE1331US01, AE1015US16, YE1071US04, YE1071US03

Distribution pattern

device · product 8 of 8

Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Z-0759-2023

Recall number: Z-0759-2023
Initiated: November 10, 2022
Classification: Class II
Status: Ongoing
Recalling firm: GE Medical Systems, LLC
Quantity: 250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

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

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Code information

No US Distribution. Model Number (System ID): H45571BK (DZ1315US08, VQ50927VQ, 835385929, 0835385937, IQ1398US05, IQ1398US04, IQ1398US03, IQ1398US02, A6193101, JO4026US01, JO4034US01, KE1070US01, KW1018US27, KT1066US01, LY1076US02, OM1000US04, OM1042US09, OM1042US08, OM1010US10, PK1367US01, QA1062US02, SA1345US06, SA2072US19, SA2158US09, SA2329US08, SA2308US02, SA1199US04, SA1199US03, SA1012US48, SA1058US63, SA1058US64, ZA2466US01, ZA2466US02, ZA2500US01, ZA2483US01, ZA2841US01, ZA3242US03, ZA2416US02, ZA1015US07, ZA3258US01, ZA1177US02, ZA2481US01, ZA2461US01, ZA2499US01, ZA2430US01, ZA2498US01, ZA2976US02, ZA2504US01, ZA2316US03, ZA2314US02, ZA2449US01, ZA2448US02, ZA2509US01, TN1279US02, 34118ULT34, 33054ULT01, P65021UL06, AE1006US18, AE1131US02, AE1025US06, AE1149US18, AE1149US16); H45571ZC (DZ1292US08, DZ1473US02, DZ1534US04, VQ55477VQ, DK1167US77, EG1621US32, EG1980US01, ET1031US01, 083038600786615, 083038602082015, 083038603381415, 5512UL1025, 5512UL0912, 5512UL0914, 5512UL0913, 835385974, 5512UL0838, 5512UL0839, 0835385958, 0835385967, 0835385972, 5512UL0276, 5512UL0003, 5512UL0408, 5512UL0256, 5512UL0843, 5512UL0236, 5512UL1346, 5512UL1345, 5512UL0483, IQ1580US01, IQ1297US04, IQ1399US01, IQ1398US01, A6384301, KE6093US01, KE1000US07, KE6031US01, KE6111US01, KW1055US19, KW1065US06, KW1002US04, KW1011US39, KW1011US31, KW1011US41, KW1011US40, KW1005US26, KW1126US01, KW1004US39, LB1050US06, LB1055US07, LB1055US06, LB1055US04, LB1055US05, LB1148US06, 1553UL0170, 1553UL0229, 1553UL0308, 1553UL0320, 1553UL0230, 1553UL0092, 1553UL0070, MU1018US01, NA1043US01, NG1186US02, OM1070US01, OM1073US03, OM1042US10, OM1065US06, OM1007US14, PK1300US29, PL8358US01, QA1020US08, QA1020US07, SA2330US05, SA2128US03, SA1060US18, SA2045US13, SA2045US09, SA2045US10, SA2045US11, SA2122US04, SA2072US20, SA2385US06, SA2329US13, SA1005US33, SA1005US34, SA1005US35, SA1118US21, SA1245US04, SA1101US06, SA2107US05, SA2107US02, SA2107US04, SA2107US03, SA2159US04, SA2513US08, SA2485US01, SA1012US56, SA1012US57, SA1034US45, ZA2899US01, ZA2745US01, ZA2858US01, ZA2786US01, ZA2279US02, ZA2577US01, ZA2787US01, ZA3145US01, ZA2765US01, ZA2626US01, ZA1047US01, ZA2656US02, ZA2670US02, ZA2800US01, ZA1850US02, ZA2699US01, ZA1030US17, ZA2545US02, ZA2902US01, ZA2986US01, ZA2767US04, ZA2595US01, ZA2702US01, ZA2970US05, ZA2900US01, ZA2793US01, ZA2788US01, ZA2726US02, ZA2754US01, ZA2735US01, ZA2789US01, ZA2602US01, ZA2955US01, ZA1030US16, ZA1018US01, ZA2141US02, ZA2141US01, ZA2567US02, ZA2940US01, ZA1850US03, ZA2685US01, ZA2177US02, ZA2137US02, ZA2976US01, ZA2965US01, ZA2273US03, ZA2818US01, ZA2772US02, ZA2749US01, ZA2853US01, ZA2819US01, ZA2851US01, ZA2687US02, 138691US01, P06043UL12, 06002ULT36, 06008ULT57, 06002ULT43, 16032ULT12, 25001ULT20, 34418ULT15, 34373ULT18, 34006ULT26, 34006ULT23, 35001ULT19, 46003ULT14, 33043ULT03, 33043ULT02, 59019ULT07, P71003UL13, P07012UL07, P65005UL04, UG1051US04, AE1353US03, AE1003US16, AE1477US04, AE1160US10, AE1477US05, AE1540US01, AE1554US01, AE1388US04, AE1062US02, AE1009US21, AE1009US22, AE1017US14, AE1017US19, AE1045US11)