GE Healthcare Brivo XR 285 Mobile general purpose radiographic… — Class II medical device recall Z-0200-2013
Terminated recall by GE Healthcare, LLC, reported 2012-11-28, distributed nationwide. It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo
| Recall number | Z-0200-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-09-20 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 364 units |
| Reason classes | software |
| Model numbers | 5555000, 5555000-2 |
Product
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
Reason for recall
It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54.
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-0200-2013. 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.