Product Safety Recalls

Product Safety Recalls

Product Recall Tracker

GE Medical Systems, LLC Recall 91139

Page Last Updated: January 16, 2024

Description: 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).

GE Medical Systems, LLC Recall 91139 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0753-2023
Event ID91139
Event DescriptionVivid 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).
Product TypeDevices
DistributionWorldwide - 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.
Quantity5,145 units
Recall ReasonPotential 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.
Device Classification20221228
Device Code InfoModel 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, 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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, 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2168118U01, 110939U009, 1823354U02, 1418517U05, 104658U004, 110604U036, 113128U042, 113128U046, 109341U007, 2139981U08, 2139981U09, 147992U003, 2139981U07, 120609U004, 2139981U02, 2139981U10, 4537138U01, 148208U004, 1937574U06, 2009258U02, 138780U006, 104040U006, 104080U010, 109537U008, 2372101U01, 4820609U02, 2431481U01, 110560U028, 104592U003, 104044U004, 138036U035, 1930392U23, 1930392U22, 109672U006, 109097U005, 1557297U09, 1447625U06, 120041U025, 104046U002, 110355U011, 2496472U01, 2193178U01, 110127U011, 110128U011, 141092U015, 103301U703, 103301U565, 120050U058, 2189160U01, 2217872U01, 110203U010, 109045U021, 2047099U01, 120056U019, 146403U005, H5085US01, H14052US02, H2080US29, H66071US01, H2032US13, H5088US01, H2035US08, H5211US01, H4193US02, H4015US02, H1427US02, H2071US06, H2065US09, H5290US01, H1890US02, VS63790VS6, IS1002US01, IS1001US06, 083038821012210, 083038821462120, 083038101030610, 083038600305710, 083038201040010, 083038041032110, 083038041032111, 083038600312210, 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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, 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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
Center Classification Date20221222
Recall Initiation Date20221110
Termination Date, BG4572US06, BG4600US01, BG4551US02, BG4655US01, 905848VS6A, 506862VS6, 877718VS6, 905534VS6, 416462VS6A, HR4020US03, HR4049US01, HR4131US03, HR4008US14, HR4008US13, CY1157US01, CZ6598US01, CZ6644US01, CZ6010US03, CZ6149US03, CZ4015US44, CZ6028US08, CZ4015US42, CZ4015US43, CZ4015US32, CZ6708US01, CZ4012US16, CZ4047US12, CZ6572US01, CZ6461US05, CZ6645US01, CZ6461US06, CZ4137US06, CZ4019US09, CZ4113US10, CZ4113US13, CZ4091US02, CZ6009US23, CZ4013US09, CZ6877US01, CZ6586US01, CZ6003US03, CZ6018US15, CZ4013US07, CZ6161US06, CZ6669US01, CZ6026US31, CZ6796US01, CZ6217US07, CZ6217US06, LV4060US01, CZ6192US02, CZ6100US04, CZ6522US02, CZ4033US03, CZ6574US01, CZ6694US02, CZ6535US03, CZ6150US02, DK1083US58, DK1047U105, DK1047U109, DK1047U118, DK1047U136, DK1047U122, DK1004US13, DK1288US03, DK1185US02, DK1030US50, DK1031US55, DK1079US25, DK1079US15, DK1386US01, DK1043US38, DK1108US24, DK1108US20, DK1424US05, DK1000US27, DK1048US05, DK1009US17, DK1059US43, EG6004US02, EE4024US14, EE4019US22, EE4089US02, FI1126US04, FI1012US06, FI1479US01, FI1019US13, FI1030US11, FI1155US03, FI1015US53, FI1021US16, FI1021US17, FI1025US20, FI1025US21, FI1289US03, FI1272US01, FI1003US53, FI1003US50, FI1003US54, FI1003US51, FI2004US01, 9160VS6, U456706901, U409199701, US67214611, U256826203, U256826204, U454285201, U323016001, USM4476519, US67483403, USM4161613, U471419101, USM4017506, US29089405, U460069801, U287345802, USM4163014, USM4163020, USM4163015, US73018016, U104546807, U104546803, U383482101, U280465001, U204016002, US06756001, US48271606, USM4478214, USM4478213, USM4478212, USM4478211, US78034311, US78034308, USN4172701, US61709105, USM4166010, USM4166006, U312751203, U312751202, U401871501, US66717107, U239027718, US75547811, US75547809, USM1607005, US75547810, US75547807, U218322803, U98381328, U98381323, USM4168204, 4326VS6, U362597102, US24297401, USM2722422, USN4630503, US70725813, U151303606, US15001708, U205963804, U456133001, US37008601, U175750004, U471441701, U384031301, U383485101, US15000406, U175562105, U101513302, US80000806, US80000805, U464196001, USN4234207, USN4234209, USN4234206, USN4234211, USN4234201, U227981502, U168571105, U216620812, U380258701, US88057105, US88057104, USM4173009, US26671808, USM1582901, U363935301, U330984501, US69059310, US42330204, US62664119, UM80004501, U200411604, U200411603, USM4173510, U350520901, U355459501, US4175802, U475531301, U203073002, U121951004, U243684703, MQ1078US03, MQ1078US3, U228270304, U252056202, U214652606, U152870606, USM4176503, USM4482609, USM4001302, US59715903, USM4463923, USM4463921, U169514802, USM4463924, U192589802, U257401014, U416545301, U123378703, USM0025902, U207711802, GF1006US04, USM4181474, US10001306, US10001305, U130810402, USM4180805, USM4485905, USM4548304, USM4548503, 8563VS6, US41820009, USM3168007, U349933501, USO4185501, US62967909, USM4186005, USN4464301, USM4464303, U202618802, U262146001, U179037602, US15003104, U253891202, USM9957405, U370680701, UM15001502, U633546201, U98381312, U98381307, US55554114, US55554117, U98381306, US55554112, U98381309, USM4024506, U98381304, USM4024503, U98381308, U98381310, U98381311, U190255013, U190255011, U190255014, U190255015, U190255016, U127219603, US64559805, U129771605, USM2851009, USM2851003, USM2851004, USM2851002, U356607301, US67682903, US29087605, US57401004, U129771606, U123467902, U150668903, U417418101, USM5156803, U269652601, U136818212, USM4488016, U255961602, U101610803, US29353001, US2746002, US51831605, USM4490405, UM75732310, U203665505, U203665506, USM2264705, USM2605505, USM2838403, U180393008, US78043909, US20002727, U383283701, U396387701, U210216902, U463266901, U394474501, USN9190114, U222593302, U396293701, U395131301, U338030501, USM7412801, US2733410, U106033031, 8264VS6, US26372302, U289468801, USA6331001, U402959901, USM4464418, USM4464419, USM4464420, U393994101, US55000309, U255588604, U343886701, USM3186731, MDP8233306, US25013104, U473695801, 8930VS6, 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Recalling FirmGE Medical Systems, LLC
Initial Notification Letter
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