GE Healthcare Optima XR 200 amx with Digital Upgrade — Class II medical device recall Z-0450-2013
Terminated recall by GE Healthcare, LLC, reported 2012-12-05, distributed nationwide. GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima
| Recall number | Z-0450-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-08-01 |
| Classified | 2012-11-29 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2013-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 217 installed |
| Reason classes | software |
| Model numbers | 5421698 |
Product
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Reason for recall
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
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-0450-2013. 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.