Definium 656HD & Discovery XR656HD — Class II medical device recall Z-1043-2025
Ongoing recall by GE Medical Systems, LLC, reported 2025-02-12, distributed nationwide. The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, wit
| Recall number | Z-1043-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-01-28 |
| Classified | 2025-02-03 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CH, CL, CN, CO, CY, CZ, DE, DO, EE, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IQ, IS, IT, JM, JO, JP, KE, KR, KW, LK, LT, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VN, ZA |
| UPC / GTIN / UDI-DI | 00195278840226, 00840682136709, 00840682138598 |
Product
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Reason for recall
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still appears on the screen when the AEC limit is reached.
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-1043-2025. 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.