GE Medical Systems, LLC Vivid i 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vivid i 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).
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
No US Distribution. Model Number H45561AC, System ID: DZ1237US02, AO1015US01, EG1843US01, EG5882US01, EG1621US04, EG1621US03, 2538978U01, 083038042857318, 083038602007811, 083038602826113, 0835384095, IQ1165US05, IQ1376US01, KE1049US01, KW1010US04, KW1102US04, KW1001US35, KW1011US21, KW1011US22, KW1006US14, KW1098US06, KW1020US15, KT1061US01, KT1062US02, LB1359US04, 1553UL1026, 0834380243, 0834384085, 0834384095, MA1251US13, MA1272US10, OM1042US03, OM1007US11, OM1007US12, PK1331US08, PK1331US06, PA1097US01, SA1201US02, SA1014US07, SA1337US05, SA1060US08, SA1147US05, SA1149US03, SA1051US09, SA2220US02, SA2220US01, SA2072US17, SA1028US06, SA1089US07, SA1138US05, SA2158US07, SA1340US02, SA1223US15, SA1002US08, SA1036US06, SA1025US03, SA2214US03, SA1272US10, SA1024US04, SA1101US04, SA1034US20, SA1249US11, SA1034US23, SA1058US60, SA1058US47, SA1058US59, SA1332US03, SA1030US05, SA1282US05, ZA2573US01, ZA2422US01, ZA2328US01, ZA2339US01, ZA2420US01, ZA1024US07, ZA2348US01, ZA2358US01, ZA1030US10, ZA2421US01, ZA1025US16, ZA1025US25, ZA2378US01, ZA2510US01, TN1028US04, 01002ULT25, 06004ULT19, 07021ULT02, P34189UL17, 21002ULT18, 23002ULT06, P23003UL12, 32004ULT18, 34013ULT13, 34037ULT16, 34013ULT14, P35076UL03, 38006ULT08, 42002ULT12, 42002ULT10, P50005UL02, 55001ULT13, 60001ULT07, P61029UL05, AE1283US01, AE1353US01, AE1016US16, AE1016US14, AE1016US15, AE1011US18, AE1331US01, AE1015US16, YE1071US04, YE1071US03
Products Sold
No US Distribution. Model Number H45561AC, System ID: DZ1237US02, AO1015US01, EG1843US01, EG5882US01, EG1621US04, EG1621US03, 2538978U01, 083038042857318, 083038602007811, 083038602826113, 0835384095, IQ1165US05, IQ1376US01, KE1049US01, KW1010US04, KW1102US04, KW1001US35, KW1011US21, KW1011US22, KW1006US14, KW1098US06, KW1020US15, KT1061US01, KT1062US02, LB1359US04, 1553UL1026, 0834380243, 0834384085, 0834384095, MA1251US13, MA1272US10, OM1042US03, OM1007US11, OM1007US12, PK1331US08, PK1331US06, PA1097US01, SA1201US02, SA1014US07, SA1337US05, SA1060US08, SA1147US05, SA1149US03, SA1051US09, SA2220US02, SA2220US01, SA2072US17, SA1028US06, SA1089US07, SA1138US05, SA2158US07, SA1340US02, SA1223US15, SA1002US08, SA1036US06, SA1025US03, SA2214US03, SA1272US10, SA1024US04, SA1101US04, SA1034US20, SA1249US11, SA1034US23, SA1058US60, SA1058US47, SA1058US59, SA1332US03, SA1030US05, SA1282US05, ZA2573US01, ZA2422US01, ZA2328US01, ZA2339US01, ZA2420US01, ZA1024US07, ZA2348US01, ZA2358US01, ZA1030US10, ZA2421US01, ZA1025US16, ZA1025US25, ZA2378US01, ZA2510US01, TN1028US04, 01002ULT25, 06004ULT19, 07021ULT02, P34189UL17, 21002ULT18, 23002ULT06, P23003UL12, 32004ULT18, 34013ULT13, 34037ULT16, 34013ULT14, P35076UL03, 38006ULT08, 42002ULT12, 42002ULT10, P50005UL02, 55001ULT13, 60001ULT07, P61029UL05, AE1283US01, AE1353US01, AE1016US16, AE1016US14, AE1016US15, AE1011US18, AE1331US01, AE1015US16, YE1071US04, YE1071US03
GE Medical Systems, LLC is recalling Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obs due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.