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

Summary

The FDA issued a Class II for Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging an by GE Medical Systems, LLC. Reason: 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 f.

Details

Product Description

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).

Lot/Code Info: No US Distribution. 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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)

Quantity Affected: 1,400 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-11-10

Company