Vivid i ultrasound — Class II medical device recall Z-0756-2023
Ongoing recall by GE Medical Systems, LLC, reported 2022-12-28, distributed nationwide. Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can
| Recall number | Z-0756-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-11-10 |
| Classified | 2022-12-22 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
| Quantity | 7,931 units |
| UPC / GTIN / UDI-DI | 00082438030118, 00082438040094, 00082438040155, 00082438040216, 00082438050031, 00082438070183, 00082438080052, 00082438090129, 00082438090228, 00082438090242, 00082438090266, 00082438090334, 00082438100255, 00082438120451, 00082438130054, 00082438130139, 00082438140138, 00082438140176, 00082438140190, 00082438150045, 00082438150083, 00082438160143, 00082438160181, 00082438160259, 00082438160389 and 14 more |
| Model numbers | 00020ULT09, 00060ULT09, 00084ULT07, 00095ULT35, 00341ULT01, 00432ULT17, 00432ULT18, 00507ULT01, 00991ULT07, 020991VI, 030295US07, 06213ULT01, 06233ULT02, 070050US03, 082438040068, 082438040103, 082438130037, 082438160153, 082438210056, 082438230020, 083037824000113, 083038005103866, 083038202081314, 083038205101045, 083038205102655 and 475 more |
Product
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). 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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0756-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.