FDA Device recall Z-2256-2012
Optima XR200amx
- FDA Device
- Class II
- terminated
- Published 2012-09-19
On 2012-09-19 the FDA classified a Class II recall of Optima XR200amx by Ge Healthcare, citing 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, al….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2256-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-10 |
| Published | 2012-09-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Reason
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.
Identifiers
| code_info | Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6. |
|---|
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-2256-2012%22
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