Class 2 Device Recall Vivid S5

• Date Initiated by Firm: November 10, 2022
• Date Posted: December 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0752-2023
• Recall Event ID: 91139
• 510(K)Number: K071985 K092079 K102393 K121063
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: 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).
• 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, 2139981U11, 2139981U12, 139561U006, 2119365U01, 147975U011, 800587U004, 800587U003, 802008U009, 802501U006, 802501U007, 1930392U27, 1930392U20, 2112894U02, 109097U016, 120041U024, 1712476U02, 2184972U01, TP9041U020, 110597U012, 800588U004, 2278297U01, 119436U049, H7050US01, H5121US01, H4107US01, H5132US01, H5083US01, H4884US04, H6977US01, H4320US02, H5231US01, H6958US01, H1902US02, H5321US01, H5260US01, H4020US02, H5381US01, H5089US01, H5201US10, H5036US01, H5303US01, 828380388, IL4284US01, IL4270US01, IL4742US01, A5413835, A6182901, A5195207, A6269102, A5936705, A5190956, A5417327, A6055001, A5108903, A5286835, B5194026, A5375127, A6101101, A5940303, A51149113, D5408601, D5111642, A6054101, A6085101, A150264812, A5646704, A5992802, A6071401, A154882803, A6085301, A6219302, F5408601, A5959103, A5977702, A5416805, A5699203, JO1126US01, KA4001US01, KA4006US01, KA1182US08, KA2809US01, KA1136US01, KA4065US01, KA1001US04, KA4122US01, KA2741US04, KA4126US01, KO1099US01, LY1138US01, 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, VS5182VS5, VS52541VS5, VS51917VS5, VS51328VS5, VS5121VS5, VS55069VS5, VS51951VS5, VS51916VS5, VS51867VS5, VS51732VS5, VS51893VS5, VS51798VS5, VS51818VS5, VS51961VS5, VS51929VS5, VS52274VS5, VS51938VS5, VS52405VS5, VS51952VS5, VS51863VS5, VS53268VS5, VS51748VS5, VS52345VS5, VS51934VS5, VS51713VS5, VS54349VS5, VS54353VS5, 2857307, VS5970VS5, DK1023US19, FI1333US02, FI1353US01, U195829529, US94752218, US62831503, US78862406, U224651901, U470233401, U357117101, U198290621, U198290620, NC1070US01, US26369503, U168890003, U223199701, US94752222, US94752228, US94752241, US94752253, US94752276, US94752325, US94752345, US94752366, US94752384, US94752399, US94752428, US94752502, 138558U002, 2271861U01, 146360U002, 140543U002, 103141U013, 803162U003, 148102U008, 112013U011, 1787856U02, 138545U009, 145135U016, 2670324U01, 104068U006, 1464242U05, 2102650U01, 109074U005, 138420U005, 2305461U01, 100011U017, 104007U056, 7422331U01, 110814U002, 110052U019, 122016U036, 110522U003, 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083038601107913, 083038802002310, 083038005102749, 083038241015410, 083038601033010, 083038280410210, 083038280016928, 083038041017910, 083038041037710, 083038040109211, 083037607932114, 083037803981014, 083038600306810, 083038600312111, 083038861020510, 083038041031710, 083038041031711, 083038040143612, 083038868531510, 083038862859710, 083038866626510, 083038861014010, 083038861040610, 083038021059111, 083038201034210, 083038821022510, 083038240062711, 083038201009410, 083038002860010, 083038860507910, 083038861050610, 083038802862510, 083038201015510, 083038806200110, 083038101100211, 083038105103069, 083037201021612, 083038002860910, 083038201447610, 083038005103569, 083038802002410, 083038245103109, 083038860515211, 083038862585310, 083038865258510, 083038802871810, 083038000052410, 083038801016910, 083038025103509, A212054602, A6091401, A5267825, A5117913, A6129501, A5936708, A5957303, A5325416, A6071301, A5658307, A6082201, A152185002, A6051601, B58208103, A6095901, A5108271, 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VS61601, VS61726, VS6R0125, VS6R0379, VS61994, 0004182303A, VS61382, VS61117, VS61112, VS62112, VS61057, VS61124, VS60637, VS60635, VS61324, VS61350, VS62238, VS60657, VS62308, VS6MB617, VS61743, VS6R2342, VS51587, VS6R0817, AH4001US49, 010120US17, 519432VIV1, 416778VS6A, 416422VS6, 416691VS6A, HR4236US01, CZ4015US45, CZ6674US01, CZ6570US01, CZ6027US03, CZ4046US05, CZ6247US04, CZ6713US01, CZ6535US02, DK1029US18, VS500620, H5095US01, H5950US01, H4538US02, H2112US06, H1093US39, HU1713US01, A5665503, PL0335US02, PL5006US01, PL3930US02, PL0514US02, PL3247US01, PL0368US01, PL3248US01, PL3963US01, PL0495US01, RO4734US01, RO4643US01, RO4068US05, RO4638US04, RO4677US01, RO4666US01, SK4451US01, SK4424US01, SK4355US01, SI4122US02, SI4039US06, BD003US12); H45041PP (0828380107 0828380252); H45041QF (83091556929, 83093607753, AP1314US03, AP5410US03, AH4323US67, AH5404US11, AP6493US02, AH5481US12, AP7699US01, AH3210US14, AP6895US02, AP8622US01, 030806US02, 110022US19, 190226US13, 348263US01, 110042US17, VS58024VS5, VS58176VS5, VS58171VS5, VS58251VS5, VS58796VS5, VS58204VS5, VS58193VS5, VS58199VS5, VS5429707WX3, VS58250VS5, VS58197VS5, VS5008249VS5, VS58249VS5, VS58220VS5, VS58236VS5, 6073UL0200, 6073UL0191, 6073UL0284, 6073UL0023, 6073UL0016, 6073UL0094, VS58135VS5, 082438290076, 082438050051, 082438050054, VS58392VS5, VS58380VS5, DK1350US01, DK1167U144, DK1047U112, DK1022US29, DK1000US22, U146529602, 4946384U02, 151032U002, 2767164U01, 145297U034, 3932057U01, 148248U008, 148315U005, 2870502U02, 139632U005, 145424U080, 803162U004, 110266U025, 1582124U01, 138545U013, 108155U002, 4876664U01, 103135U051, 145712U024, 1521538U03, 1082501U01, 122024U026, 142464U024, 110644U012, 1888092U02, 2327918U01, 142494U006, 1316489U02, 110284U017, 5822827U01, 149615U015, 140032U031, 2050092U05, 120139U045, 112037U061, 1975547U03, 120122U032, 110600U012, 110600U006, 110600U015, 110600U007, 2585795U01, 4040833U02, 2622220U03, 1669919U03, 110238U007, 2551098U01, 138251U021, 4085695U01, 142836U004, 801164U008, 150789U002, 138502U005, 2397191U01, 109787U004, 2184972U02, 2108250U87, 139989U011, 2552324U05, 110456U025, H6024US01, H5799US01, H5871US01, VS58413VS5, VS58492VS5, VS58435VS5, 0828380390, 0828380391, 0828380412, HU1387US02, HU1900US02, 083038860535514, 083037800001915, 083037800011915, IE1018US25, A5109222, A5566974, A404735601, A5805545, A5645335, A5954603, A6192501, B5315359, 0850370799, 0850370776, 0850370668, 0850370500, 0850371131, 0850371274, 0850371275, 0850371397, 0850371559, 0850371641, 0850371662, 0850371726, 0850371736, 0850371891, 0850371970, 0850371995, 0850372028, 0850372047, 0850372056, 0850372149, 0850372256, 0850372437, 0850372514, 0850372610, 0850372648, 0850372772, 0850372843, 0850373110, 0850373336, 0850400212, 0850370455, 85096805326, VS57351VS5, 1557UL0044, 1557UL0136, 1557UL0328, 1557UL0330, 1557UL0047, 1557UL0281, 1557UL0363, 1557UL0139, 1557UL0087, 1557UL0242, 1557UL0241, 1557UL0243, 1557UL0062, 1557UL0042, 1557UL0135, 1557UL0046, 1557UL0329, 1557UL0216, 1557UL0088, 1557UL0138, 1557UL0364, 1557UL0283, 1557UL0089, 1557UL0246, 1557UL0060, 1557UL0282, 1557UL0326, 1557UL0231, 1557UL0244, 1557UL0234, 1557UL0365, 0843374508, 1557UL0327, 1557UL0043, 1557UL0063, 1557UL0045, 0843384118, 0843384119, 0843384120, 0843384125, 0843384128, 0843384129, 0843384133, 0843384134, 0843384135, 0843384136, 0843384138, 0843384139, 0843384140, 1557UL0233, 1557UL0245, 1557UL0232, 1557UL0061, 1557UL0137, P00141US01, PL3051US02, PL1023US18, PL3276US03, PL1270US02, PL3181US01, PL1896US09, PPR71604, PPR97501, PPR59053, VS57512VS5, VS58350VS5, VS57144VS5, RU1016US09, RU9481US02, RU8104US01, RU5248US05, RU2147US05, RU5491US03, RU9723US01, RU5354US04, RU5234US02, RU7189US03, RU7189US04, RU3589US02, RU7808US01, RU8116US01, RU7872US01, RU7873US01, RU7825US03, RU2000US02, RU6261US07, RU2426US02, RU8149US01, RU8149US02, RU8149US03, RU7639US01, RU2169US07, RU6526US02, RU9168US01, RU1962US03, RU8153US01, RU5442US03, RU4952US04, RU4862US03, RU6125US02, RU3640US04, RU2659US03, RU3459US05, RU7037US02, RU7775US01, RU8148US01, 0853380345, 0853380351, 0853380360, 0853380367, 0853380370, 0853380389, 0856380263, 0856380273, 0856380337, 00002ULT21, 179655002, 179655006, 179655010, 179655014, 179655018, 1943139902, 1949116772, 194578992, 183627142, 148162352, 156958552, 183697416, 179594172, 00044ULT17, 00331ULT06, 174764952); H45041RJ (VS5R7703, VS5R8374, VS58563, VS58518, VS5R7879, VS5R7695, VS5R0828, 180043US10, 180083US04, 180083US05, 810749US01, BA4185US01, BG4603US01, CZ6323US05, UM29072401, U154358408, US94752221, GP1107US03, US51303606, USM2322202, US72062907, UMT4440401, US94752386, US94752551, US94752576, US94752585, US94752634, US94752645, US94752662, USM4475009, 146428U006, 7459711U01, 2551431U02, 101154U027, 2193178U03, 1926827U19, 4015799U01, H4871US01, H1969US60, H4855US01, H5339US01, H6569US01, H14051US04, PL0388US01, PL0456US02, PL3794US03, PPS22701, RO1099US04, RO1435US01, RU8352US01, RU8368US01, RU8344US01, RU8501US02, RU8166US01, RU8930US01, RU9734US01, RU9845US03, RU9842US02, RU8609US01, RU9700US01, RU9643US01, RU9301US01, FE385908, 99999ULT94, P25016UL23, 28006ULT07); H45041RY (AP3006US06, AP3006US07, AP7827US01, VS55046VS5, 083038000101114, 083038602305714, 083038604107914, 083038607767014, KA2777US02, MD1098US01, RU9259US01, RU8666US01, RU8640US01, RU2688US07, RU9093US01, RU9547US01, RU9358US01, RU9245US01, RU4762US02, RU8575US01, RU8745US01, RU9590US01, RU7866US02, RU9036US04, RU9036US01, RU9094US01, RU8941US01, RU3492US02, RU8899US01, RU8810US02, RU8810US01, RU3926US01, RU4811US03, RU9451US01, RU9611US01, RU9488US01, RU8470US01, RU1799US02, RU8895US01, RU9568US01, RU8973US01, RU8634US01, RU9286US01, RU8225US04, RU8360US01, RU8435US01, RU9007US01, RU9030US01, RU9031US01, RU9359US01, RU9067US02, RU8608US01, RU7950US03, RF0159US04, RU8956US01, RU8602US01, RU9392US01, RU9438US01, RU1326US02, RU9419US01, RU9623US01, RU8952US01, RU6482US03, RU8295US01, RU8371US01, RU8560US01, RU8561US01, RU8562US01, RU8563US01, RU8564US01, RU8565US01, RU8632US01, RU8689US01, RU8735US01, RU8812US01, RU9018US01, RU9091US02, RU9398US01, RU9820US01, RU9267US02, RU8791US01, RU2371US08, RU9436US01, RU9085US01, RU9348US01, RU9502US01, RU9600US01, RU9315US01, RU7179US03, RU7953US02, RU8399US01, RU8400US01, RU8401US01, RU8402US01, RU8403US01, RU8404US01, RU8405US01, RU8446US01, RU8496US01, RU7825US04, RU9638US01, RU8458US01, RU8458US02, RU8494US01, RU8968US01, RU8968US02, RU9480US01, RU1612US05, RU8437US01, RU8741US01, RU6490US04, RU9416US01, RU8858US02, RU8251US01, RU8587US01, RU8587US02, RU9431US01, RU8880US01, RU6194US02, RU9042US02, RU4643US02, RU6197US02, RU8559US01, RU8652US01, RU8998US01, RU9102US01, RU9413US01, RU9608US01, RU9622US01, RU8358US01, RU8897US01, RU9294US01, RU9576US01, RU9523US01, RU1245US03, RU9409US01, RU8480US01, RU7432US02, RU8574US01, RU9531US01, RU3684US02, RU9432US01, RU9439US01, RU9177US01, RU5451US02, RU9219US01, RU6030US02, RU9150US01, UA4594US03, UA4306US01, UK1150US01, UA4300US01)
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: GE Healthcare notified consignees on about 11/10/2022 via letter titled "URGENT MEDICAL DEVICE CORRECTION. For U.S. customers, letters were sent via FedEx. Consignees were instructed to follow updated safety instructions provided in the appendix included with the notification letter, place the appendix with the product labeling, and replace the batter every 2 years or if the battery is not capable of powering the system for more than 30 minutes. In response, GE Healthcare requested consignees return the response form.
• Quantity in Commerce: 5,649 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYN and Original Applicant = GE MEDICAL SYSTEM ISRAEL LTD.; 510(K)s with Product Code = IYN and Original Applicant = GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.; 510(K)s with Product Code = IYN and Original Applicant = GENERAL ELECTRIC CO.