Class 2 Device Recall Vivid S5 N

• Date Initiated by Firm: November 10, 2022
• Date Posted: December 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0754-2023
• Recall Event ID: 91139
• Product Classification: System, imaging, pulsed doppler, ultrasonic - Product Code IYN
• Product: 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).
• 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, ZA1025US06, DE6588117, 0853380181, 0853380190, 0853380201, 0853380218, 0853380224, 0853380227, 0853380275, 0853380291, 0853380292, 0853380296, 0853380301, 0853380303, 0853380305, 0853380311, 0853380313, 0853380316, 0853380322, 0853380323, 0853380324, 0853380332, 0853380335, TN1421US01, TN1716US01, TN1434US01, TN1912US01, TN1432US01, TN1428US01, TN1350US02, TN1436US01, TN1429US01, TN1513US03, TN1418US01, TN1143US03, TN1426US01, TN1571US03, TN1270US02, TN1356US02, TN1696US01, 01036ULT01, 01036ULT03, 01036ULT02, 03009ULT01, 06008ULT32, P35080UL06, 16032ULT01, 26019ULT01, 26016ULT06, 26019ULT02, P35005UL07, P34282UL03, 34091ULT17, 34009ULT25, 34288ULT05, P01046UL01, 38014ULT01, 38014ULT02, P54028UL05, P45011UL02, P34505UL03, 53007ULT01, 47004ULT01, AE1020US16, AE1126US07, VS6177VS5); H45561HE (VS50909, VS50923, VS51297, VS51464, VS51659, VS52501, VS51273, DZ1057US08, DZ1358US01, DZ1380US01, DZ1509US01, DZ1521US01, DZ1467US01, DZ1352US01, DZ1057US05, DZ1057US09, DZ1434US01, DZ1468US01, DZ1447US01, DZ1563US01, DZ1042US02, DZ1425US01, DZ1009US09, DZ1351US01, DZ1555US01, DZ1457US01, DZ1516US01, DZ1540US01, DZ4254US01, DZ1514US01, DZ1282US03, DZ1407US01, DZ1418US01, DZ1343US04, DZ1419US01, DZ1417US01, DZ1453US01, DZ1537US01, DZ1510US01, DZ1408US02, DZ1448US01, DZ1292US03, DZ1372US01, DZ3618US01, DZ1573US01, DZ1532US01, DZ1413US01, VS52350VS5, VS54365VS5, VS55128VS5, VS54275VS5, VS54252VS5, VS55143VS5, VS51509VS5, VS54249VS5, VS55134VS5, VS51716VS5, VS54084VS5, VS51616VS5, VS52154VS5, AZ4010US01, AZ4041US01, VS52361VS5, VS54491VS5, VS54040VS5, VS52436VS5, VS53752VS5, VS50839VS5, VS51128VS5, VS52356VS5, VS52424VS5, VS52359, VS52430VS5, VS51977VS5, VS58246VS5, VS5113VS5, VS57569VS5, VS57116VS5, VS52420VS5, VS50026VS5, VS5159VS5, VS55211VS5, VS55039VS5, VS52248VS5, VS55067VS5, VS52471VS5, VS55208VS5, VS53461VS5, VS51933VS5, VS5130VS5, VS55079VS5, VS55074VS5, VS52305VS5, VS51605VS5, VS5108VS5, VS51295VS5, VS52289VS5, VS54560VS5, VS52448VS5, EG5619US02, EG6012US02, EG5895US01, EG5619US01, EG5733US02, EG5619US03, EG5624US01, EG5841US01, EG1392US03, EG5754US01, EG5628US01, EG5639US01, EG1498US03, EG5316US05, EG5316US04, EG5316US10, EG5316US03, EG5316US08, EG5316US14, EG5784US02, EG6437US01, EG5756US01, EG1558US03, EG5858US01, EG5050US04, EG5046US08, EG5948US03, EG6102US01, EG6101US01, EG1368US10, EG5326US03, EG5988US02, EG5860US01, EG5879US04, EG5948US02, EG1412US21, EG1368US07, EG6445US01, EG5641US01, EG5174US08, EG5849US02, EG5174US09, EG6190US01, EG5836US01, EG1368US08, EG1368US09, EG5888US02, EG1424US03, EG5022US11, EG5022US05, EG5861US02, EG5662US01, EG5699US01, EG5764US01, EG5888US03, EG6189US01, EG6453US01, EG6428US01, EG6077US01, EG5865US01, EG6106US01, EG5742US01, EG5126US05, EG7216US01, EG5777US01, EG6443US01, EG5126US09, EG5703US01, EG5346US02, EG5661US01, EG5690US02, EG7215US01, EG5833US01, EG5235US03, EG5909US01, EG5758US01, EG5736US01, EG5122US12, EG5810US02, EG6225US02, EG5829US01, EG1345US07, EG6003US01, EG5383US05, EG6378US01, EG5783US02, EG5744US01, EG5128US05, EG5687US01, EG5898US01, EG5640US01, EG1490US02, EG6398US02, EG6398US01, EG5864US01, EG6550US02, EG6375US01, EG5630US02, EG5097US03, EG5995US01, EG6406US02, EG6413US01, EG5250US06, EG5250US03, EG5250US04, EG5387US05, ET1016US01, ET1009US01, UN07359001, GE1137US01, 1498952U02, 2017975U02, 145771U037, 148112U009, 2308187U01, H2016US20, VS52346VS5, 083038822825879, 083038605284713, 083038602001813, 083038602000112, 083038602002412, 083038602003613, 083038602000911, 083038602001915, 083038602003511, 083038602005111, 083038602007813, 083038603579112, 083038025105099, 083038066705610, 083038602004311, 0835385934, 0835385935, 0835385943, 0835385944, 0835384085, 0835384096, 0835384097, 0835384102, 0835384103, 0835384106, 0835384113, 0835384116, 0835384119, 0835385925, 0835385926, 0835385932, 0835385933, 0835385940, 0835385931, 0835385942, 5512UL2483, IQ1336US01, IQ1268US04, IQ1577US01, IQ1286US01, IQ1291US01, IQ1316US01, IQ1338US01, IQ1316US02, IQ1289US01, IQ1288US01, IQ1065US03, A6064301, A5401382, E5346306, DFA001, DF9002, DF9005, JO4061US08, JO4028US01, JO1136US01, JO1021US01, JO4048US01, 0850US6210, KW1006US09, KT1067US05, KT1060US01, KT1072US01, KT1067US04, LB1331US04, LB1381US01, LB1362US01, LB1047US01, LB1327US01, LB1312US01, LY1086US07, LY1106US01, LY1100US01, LY1096US01, LY1105US02, LY1086US06, 0834375608, 0834375609, 0834375611, 0834384077, 0834384097, 0834384099, 0834384100, 0834384102, 0834384108, 0834384307, 0834384103, 0834374466, 0834384080, 0834384092, 0834384093, 0834384305, MU1009US02, VS51576, VS51571, MA1499US01, MA1367US02, MA1464US01, MA1294US01, MA1403US02, MA1294US02, MA1236US02, MA1456US01, MA1505US01, MA1263US02, MA1219US03, MA1506US01, MA1507US01, MA1272US11, MA1466US02, MA1466US01, MA1463US01, MA1462US01, MA1476US01, MA1330US02, MA1243US03, MZ0020US01, VS50966VS5, NG1126US01, NO4195US02, OM1053US02, OM1024US02, PK1396US01, PK1376US03, PK1300US12, PK1420US01, PK1367US02, PK1708US01, PK1363US01, PK1000US02, PK1385US02, PK1304US02, PK1044US03, PK1255US09, PK1303US02, PK1380US01, PK1386US02, PK1194US03, PK1386US03, PK1350US01, PK1348US01, PK1398US01, PK1341US01, PK1251US02, PK1185US02, PK1035US18, PK1378US01, PK1317US03, VS53402VS5, 2453VS5, VS53528VS5, VS53434VS5, VS52090VS5, 2363VS5, PPS07807, VS54055VS5, VS53449VS5, VS57019VS5, SA1232US19, SA2202US01, SA1228US03, SA1056US34, SA1058US43, ZA1025US23, ZA1025US08, FPG09701, MPX93300, SY2054US01, SY1052US01, SY2048US01, SY2062US02, SY2063US01, SY1057US01, SY2065US01, SY1012US03, SY2062US01, SY1057US02, SY2066US03, SY2057US01, SY1009US03, TZ1073US03, TZ1021US01, TN1647US01, TN1641US02, TN1652US01, TN1445US01, TN1117US01, TN1600US02, TN1654US01, TN1649US01, TN1243US08, TN1438US01, TN1651US01, TN1446US01, TN1650US01, TN1478US01, TN1076US02, TN1078US03, TN1187US04, TN1069US05, TN1536US01, TN1318US01, TN1278US03, TN1148US04, TN1543US01, TN1427US01, TN1632US01, TN1560US01, TN1422US01, TN1561US01, TN1648US01, TN1494US01, TN1514US01, TN1520US01, TN1047US02, TN1489US02, TN1653US01, TN1003US10, TN1521US01, TN1152US02, TN1861US01, TN1463US01, TN1583US01, TN1646US01, TN1656US01, TN1656US02, TN1366US04, TN1655US01, TN1008US02, TN1016US06, TN1166US04, TN1443US01, TN1482US01, P01049UL01, 01012ULT13, 01002ULT31, 01012ULT09, P01004UL02, P01040UL02, 01002ULT34, 03001ULT01, 68004ULT06, 68004ULT05, P02017UL02, P02017UL03, P06030UL18, 06213ULT02, P06176UL04, P06087UL02, 06007ULT15, 06213ULT11, 06068ULT13, 06034ULT04, P06030UL21, 06008ULT45, P06030UL23, 06004ULT17, P31040UL04, 07024ULT04, 07024ULT06, 07032ULT02, 07021ULT04, 34316ULT02, 09012ULT06, 09004ULT04, 34321ULT01, P10027UL03, 10014ULT02, P34539UL01, 11001ULT01, P13011UL01, P48008UL03, P35079UL02, 16036ULT01, P16028UL02, 16071ULT01, 16027ULT02, 16003ULT16, 16062ULT51, 16062ULT50, 17005ULT11, 17005ULT10, P34521UL01, 19008ULT17, 19008ULT03, 19006ULT02, 19008ULT02, P20008UL17, 20001ULT18, P20029UL01, P35077UL05, 21002ULT15, 21002ULT14, 21002ULT08, 21016ULT06, 21002ULT07, 21002ULT17, 21016ULT09, P10022UL02, 23002ULT09, P24011UL03, 25001ULT17, 26002ULT04, P26033UL02, 26001ULT06, P48009UL02, P27027UL01, P27024UL05, P27031UL01, 27030ULT02, P27026UL01, P41047UL01, 28006ULT02, P28008UL02, P28008UL03, P28013UL01, 31011ULT05, 31036ULT01, P76003UL03, P31036UL05, 32007ULT01, P34485UL04, P34679UL04, 34365ULT02, P34500UL07, P34488UL03, P34401UL03, P34552UL23, 34340ULT05, 34013ULT09, 34348ULT10, 34006ULT18, 34006ULT08, 34034ULT06, P34553UL01, 34006ULT09, 34378ULT01, P34543UL01, 06049ULT07, 34116ULT02, 34378ULT02, 34340ULT03, P34536UL02, P34679UL03, P34500UL09, 34078ULT17, 34286ULT04, 34021ULT12, 34378ULT03, 34365ULT01, 34225ULT03, P34500UL08, 34348ULT11, 34346ULT02, 34340ULT04, 34355ULT01, 34278ULT03, 34034ULT07, P34563UL01, P34503UL04, 34034ULT26, 34260ULT04, P35076UL02, P35092UL01, P35034UL02, P41031UL03, P63017UL02, 46008ULT01, 46009ULT01, 46001ULT01, P46009UL01, 78003ULT02, P37005UL02, 38025ULT05, 38025ULT02, 38014ULT05, 38025ULT03, P00020UL01, P00022UL01, P39007UL01, 40006ULT02, 42024ULT09, 42002ULT06, P42013UL04, P42015UL04, 42024ULT07, P42015UL03, P43009UL11, P34509UL01, 44019ULT09, P44028UL01, 44019ULT08, P45019UL02, P48031UL01, P24012UL01, P33028UL07, 33028ULT03, P33042UL01, 49003ULT02, P27028UL01, P34537UL01, P52025UL01, 80001ULT03, P53017UL01, P06175UL03, 53002ULT03, P55034UL04, P63018UL01, 63011ULT01, P01013UL16, P01048UL01, P58013UL05, P59015UL02, 59019ULT03, 59033ULT02, P61035UL01, 61006ULT01, 61012ULT01, P35074UL03, P34513UL04, P34513UL01, P65024UL01, P65025UL02, P34044UL07, 67010ULT03, 67014ULT02, AE1349US02, AE1345US02, AE1392US01, AE1304US01, AE1359US01, AE1068US02, AE1332US01, YE1080US02, YE1176US01, YE1176US02, YE1140US03, YE1181US01, YE1007US03); H45571SH (DZ1734US01, DZ2165US01, DZ1813US01, DZ1087US02, EG5160US04, EG6012US03, EG5784US03, EG5050US05, EG5859US01, EG1368US04, EG5972US01, EG6035US01, EG6598US01, EG1368US03, EG6693US01, EG5702US02, EG5699US02, EG6465US01, EG6588US01, EG6158US02, EG1368US05, EG5764US02, EG6092US03, EG1368US02, EG1368US06, EG6746US01, EG5143US02, EG5947US01, EG1382US03, EG6147US01, EG6218US01, EG6239US01, EG5791US05, EG7278US01, EG5865US03, EG5865US02, EG6166US02, EG6487US01, EG5398US02, EG6660US01, EG6129US01, EG5828US03, EG6044US03, EG6633US01, EG6633US02, EG6634US01, EG7238US01, EG5876US02, EG5786US02, EG5122US08, EG5122US06, EG5122US07, EG5892US01, EG5161US03, EG6134US01, EG6773US01, EG5208US02, EG6036US01, EG6244US01, EG6409US02, EG6388US01, EG6224US01, EG6139US01, EG5043US05, EG5995US03, EG5606US05, ET1000US02, GE1134US04, GE1161US01, GE1005US02, GE1139US02, GE1154US01, IQ1063US02, JO4070US01, JO4071US01, JO4070US02, KA2874US03, KA2983US02, KA2984US01, KT1092US01, LY1176US01, LY1010US06, LY1129US02, LY1118US01, LY1086US09, MA1608US01, MA1218US02, MA1610US01, MA1381US02, MA1543US01, MA1521US12, MA1251US18, MA1251US16, MA1565US01, MA1541US01, MA1020US21, MA1593US01, OM1028US03, OM1028US02, PK1396US02, PK1010US07, PK1482US01, PK1393US01, PK1331US07, PK1417US01, PK1468US01, PK1338US02, PK1242US04, PK1309US06, PK1309US05, PK1255US10, PK1484US01, PK1478US01, PK1452US01, PK1317US14, PK1002US03, PK1201US08, PK1317US07, ZA2562US01, ZA2590US01, ZA2653US01, ZA1025US19, TN1661US01, TN1680US01, 06051ULT11, P06209UL05, P09010UL03, 27021ULT01, P28008UL04, P16021UL02, 34094ULT11, 34037ULT26, 34094ULT12, P35097UL01, 00013ULT27, P44031UL01, 33038ULT01, P01013UL17, 59020ULT02); H45571SJ (AF1029US01, DZ1636US01, DZ1695US01, DZ1006US08, DZ1685US01, DZ2239US01, DZ1774US01, DZ3391US01, DZ1628US01, DZ1640US01, DZ1726US01, DZ1733US01, DZ1692US01, DZ1802US01, DZ1803US01, DZ4379US01, DZ1961US01, DZ1854US01, DZ2938US01, DZ1585US01, DZ1562US01, DZ1627US01, DZ1641US01, DZ1597US02, DZ2340US01, DZ1918US01, DZ2422US01, DZ1917US01, DZ1626US01, DZ1583US01, DZ1662US01, DZ1237US03, DZ1639US01, AZ4054US01, 083038603742916, CI1006US04, CZ6587US02, CZ6323US04, EG7241US02, EG5286US03, EG6511US01, EG6045US01, EG5962US01, EG5316US06, EG6591US02, EG5342US03, EG5200US04, EG5050US06, EG5966US07, EG6608US01, EG1283US03, EG5308US06, EG1653US04, EG5693US02, EG1324US03, EG5980US01, EG5095US17, EG6081US03, EG1621US05, EG5888US04, EG5095US16, EG1387US03, EG6582US01, EG6092US02, EG1621US06, EG6657US01, EG6097US01, EG5469US07, EG5576US02, EG6028US01, EG6603US01, EG6151US01, EG6077US02, EG5129US04, EG5129US05, EG6169US01, EG6206US01, EG5979US01, EG6597US01, EG6039US03, EG5126US10, EG6487US02, EG1396US04, EG5554US03, EG6094US01, EG5122US09, EG5810US03, EG6560US04, EG6109US01, EG5829US02, EG6948US01, EG6820US01, EG5038US03, EG5602US03, EG5857US01, EG6212US01, EG7239US02, EG5097US04, EG5907US01, EG5963US03, EG6682US01, EG6604US01, EG6606US01, EG5043US04, EG5043US07, GE1161US02, GE1139US01, GE1159US01, GH5249US01, GH1064US01, 083037602005313, 083038600113315, 083038608545716, 083038602004813, 5512UL0420, 835385975, 835385963, 835385965, 5512UL0903, 5512UL0487, 0835385956, 0835385959, 5512UL1244, 5512UL0235, 5512UL0047, IQ1091US04, IQ1634US01, JO4050US01, KT1095US01, KT1086US01, KT1091US01, KT1079US01, LY1141US01, LY1129US01, LY1094US01, LY1067US04, LY1071US03, 0834384013, 0834384008, 0834384011, 0834384012, 0834384014, 0834384015, 0834384016, 0834384017, 0834384311, 0843384007, 1553UL0140, 1553UL0498, ML1009US11, ML1009US06, MR1006US02, MA1568US01, MA1614US01, MA1577US01, MA1326US03, MA1611US01, MA1552US01, MA1553US01, MA1554US01, MA1605US02, MA1464US02, MA1551US01, MA1296US02, MA1017US10, MA1580US01, MA1020US36, MA1544US01, NG1288US01, NG1193US03, PK1362US04, PK1362US03, PK1474US01, PK1574US01, PK1384US02, PK1682US01, PK1479US01, PK1242US03, PK1419US01, PK1537US01, PK1488US01, PK1000US03, PK1461US01, PK1255US11, PK1572US01, PK1385US03, PK1451US01, PK1244US03, PK1201US09, PK1271US03, PL3276US01, PL3771US01, SA2445US01, ZA2592US01, ZA2313US02, ZA2591US01, TZ1018US11, TZ1018US12, TN1673US01, TN1624US03, TN1679US01, P01061UL02, 01084ULT03, P03013UL02, P03013UL06, P06209UL04, P06209UL03, 06151ULT01, 06177ULT01, P06118UL08, P06118UL11, 06002ULT31, P06043UL10, 06004ULT33, P31025UL11, P07089UL01, 07032ULT01, 09016UL01, P09010UL02, 10014ULT06, P72010UL04, P72010UL03, P72008UL05, P06008UL07, 11001ULT02, 14005ULT02, P16083UL01, 16027ULT06, P16075UL04, 16027ULT04, 16003ULT17, P16082UL01, P16087UL01, 16027ULT05, 16036ULT05, P16075UL05, P20012UL02, 20006ULT02, P20008UL21, P35077UL06, P20008UL20, P20008UL18, 20001ULT28, 20003ULT15, 21002ULT26, P21051UL01, 21002ULT31, P21054UL01, 22004ULT08, P23011UL11, 26001ULT17, 26001ULT18, 26001ULT20, P27023UL05, P27023UL11, P27029UL02, 27022ULT01, P28008UL05, P16021UL23, P34607UL01, 34094ULT15, P34485UL05, P34282UL15, 34094ULT14, P34594UL07, P34649UL01, P34282UL16, 34345ULT02, P34594UL06, 34034ULT29, P34552UL09, 34343ULT01, P34608UL07, P34616UL01, 34384ULT02, 34094ULT13, P34585UL01, 34009ULT31, 34433ULT12, P34540UL03, 34349ULT02, 34004ULT03, 34091ULT32, P34552UL11, 34225ULT04, 34315ULT06, P34282UL05, 34017ULT09, 34034ULT17, P34603UL01, 34395ULT04, P34282UL17, P34581UL01, 34078ULT19, 34803ULT03, P35095UL01, 35061ULT01, 35001ULT22, 35054ULT02, P35094UL01, 35004ULT14, P35104UL01, 35004ULT13, P41031UL06, P41031UL07, P33015UL09, P46012UL08, P46012UL07, 46003ULT17, 46003ULT12, 46003ULT13, P52009UL05, P52009UL04, P00028UL01, 39004ULT03, 39004ULT02, P41035UL02, P41042UL02, P41045UL01, P41045UL02, 41038ULT03, 41002ULT08, 42042ULT01, P42015UL05, P42015UL06, P43009UL06, P43009UL08, P43009UL09, P44033UL01, P45026UL01, 45001ULT09, P45033UL01, P45028UL01, P45030UL01, P47012UL03, P47012UL05, P47012UL04, P47016UL03, P33029UL03, 33037ULT03, 33022ULT04, P33036UL02, P48023UL03, 48017ULT03, P52027UL01, 54011ULT02, P54031UL01, 55025ULT04, 63011ULT13, 63009ULT05, P56005UL05, 57002ULT02, 59020ULT03, P59023UL01, 59033ULT01, P71003UL15, P63001UL16, P65005UL05, 60001ULT11, P34513UL12, P65022UL03, P65028UL02, P65028UL01, 77004ULT02, 77001ULT04, 66007ULT01, 67013ULT01, 67014ULT01, AE1526US02, AE1565US01, YE1191US01)
• 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: 1,400 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.