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GE Medical Systems, LLC Recall 91139

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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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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