1 — Class II medical device recall Z-0860-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-04-13, distributed nationwide. There is potential for the images to be flipped left to right.
| Recall number | Z-0860-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-02-18 |
| Classified | 2022-04-04 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BR, CA, CH, CN, DE, DK, EC, ES, FR, GB, GR, HK, IE, IN, IR, IT, JP, KR, KW, LB, MX, NL, NZ, PK, PL, PT, RO, RS, RU, SA, SE, SI, TR, TW, ZA |
| Quantity | 653 units |
| UPC / GTIN / UDI-DI | 00082427010077, 00082427060034, 00082427070101, 00082427090208, 00082427090246, 00082427100198, 00082427100228, 00082427150056, 00082427190069, 00082427200072, 00082427220018, 00082427240030, 00082427250060, 00082427310108 |
Product
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Reason for recall
There is potential for the images to be flipped left to right.
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-0860-2022. 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.