FDA Device recall Z-0197-2013
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0197-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-20 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
Reason
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.
Identifiers
| code_info | part number: 5421698 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0197-2013%22
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