CLASS II ONGOING Device recall · Reported 28 Dec 2022 · FDA Enforcement Report

Vivid S6 N ultrasound recalled by GE Medical Systems

GE Medical Systems is recalling Vivid S6 N ultrasound, distributed nationwide in the US. The recall was initiated on 10 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNo 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)

Quantity recalled708 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0755-2023
FDA event ID: 91139
Recalling firm: GE Medical Systems, Waukesha, WI
Classification: Class II
Status: Ongoing
Recall initiated: 10 Nov 2022
FDA classified: 22 Dec 2022
Reported: 28 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

10 Nov 2022	Recall initiated by company
22 Dec 2022	Classified by FDA	+42 days
28 Dec 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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).

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 91139

This product is part of a recall event; the main page for the event is Vivid S6 ultrasound recalled by GE Medical Systems.

Reported	Class	Recall	Company	Reason	Where
28 Dec 2022	CLASS II	Vivid S6 ultrasound recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
28 Dec 2022	CLASS II	Vivid S5 N ultrasound recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
28 Dec 2022	CLASS II	Vivid S5 Ultrasound recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
28 Dec 2022	CLASS II	Vivid q ultrasound recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
28 Dec 2022	CLASS II	Vivid q N ultrasound recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide
28 Dec 2022	CLASS II	Vivid i N ultrasound recalled by GE Medical Systems	GE Medical Systems	Other	Nationwide

More recalls from GE Medical Systems

All 160

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	Optima XR240amx, Mobile Digital Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR220amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS II	Optima XR200amx, Mobile Digital-Ready Radiographic System recalled	GE Medical Systems	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS II	Giraffe OmniBed Field Replaceable Unit (FRU) recalled	GE Medical Systems	Other	Nationwide
17 Jun 2026Device	CLASS II	Allia IGS 7 Pulse angiographic X-ray system recalled	GE Medical Systems	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide