Various GE Magnetic Resonance System on-site software version Product… — Class II medical device recall Z-0693-2019
Terminated recall by GE Healthcare, LLC, reported 2019-01-16, distributed nationwide. Possible incorrect software version loaded.
| Recall number | Z-0693-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-11-15 |
| Classified | 2019-01-07 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2021-01-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CN, CO, CY, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, GY, HK, HN, HU, ID, IN, IQ, IR, IT, JM, JP, KE, KR, KW, LB, LK, LT, LV, MA, MX, MY, NG, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SV, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 3,849 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00082427010046, 00082427030020, 00082427030044, 00082427030051, 00082427030068, 00082427030075, 00082427040081, 00082427050035, 00082427060027, 00082427060072, 00082427070064, 00082427070088, 00082427070118, 00082427080032, 00082427090062, 00082427090086, 00082427090109, 00082427090147, 00082427090154, 00082427090178, 00082427090185, 00082427090222, 00082427090307, 00082427100068, 00082427100112 and 46 more |
Product
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
Reason for recall
Possible incorrect software version loaded.
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-0693-2019. 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.