Vivid i N ultrasound. Not marketed in the US. Used in recall
Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ…
Why was Vivid i N ultrasound. Not marketed in the US. Used in 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ…
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 113 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.
- Recall date
- December 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)