510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-0754-2023Class II

Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics...

GE Healthcare / initiated 2022-11-10 / Open, Classified / root cause: design
FDA source (opens on fda.gov)

GE Medical Systems, LLC began a recall of Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-0754-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
GE Healthcare
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).
Product code
IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag
design
FDA root 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.
Product codes and lots
No US Distribution. 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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)

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0754-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0752-2023Class IIOngoingVoluntary: Firm initiated
Z-0753-2023Class IIOngoingVoluntary: Firm initiated
Z-0754-2023Class IIOngoingVoluntary: Firm initiated
Z-0755-2023Class IIOngoingVoluntary: Firm initiated
Z-0756-2023Class IIOngoingVoluntary: Firm initiated
Z-0757-2023Class IIOngoingVoluntary: Firm initiated
Z-0758-2023Class IIOngoingVoluntary: Firm initiated
Z-0759-2023Class IIOngoingVoluntary: Firm initiated