Optima XR200amx — Class II medical device recall Z-2256-2012
Terminated recall by GE Healthcare, LLC, reported 2012-09-19, distributed nationwide. Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an
| Recall number | Z-2256-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-07-10 |
| Classified | 2012-09-13 |
| Reported by FDA | 2012-09-19 |
| Terminated | 2013-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 254 in |
| Reason classes | software |
| Model numbers | 5555000-3, 5555000-4, 5555000-5, 5555000-6 |
Product
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Reason for recall
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
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-2256-2012. 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.