GE Healthcare Optima Mobile X-ray System — Class II medical device recall Z-1993-2012
Terminated recall by GE Healthcare, LLC, reported 2012-07-25, distributed nationwide. GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima
| Recall number | Z-1993-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-04-04 |
| Classified | 2012-07-19 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 254 units |
| Reason classes | software |
Product
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Reason for recall
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR200amx, ond Optima XR220amx related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
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-1993-2012. 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.