GE Medical Systems, LLC: Medical Device Recall in 2022 - (Recall #: Z-0755-2023)

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).

Class II

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.

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)

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.

Voluntary: Firm initiated