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).
This recall is currently active, issued December 22, 2022. It was issued by Ge Medical Systems, Llc.
- Company
- Ge Medical Systems, Llc
- Recall Initiated
- November 10, 2022
- Posted
- December 22, 2022
- Recall Number
- Z-0758-2023
- Quantity
- 113 units
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.