FDA Device recall Z-1993-2012
GE Healthcare Optima Mobile X-ray System
- FDA Device
- Class II
- terminated
- Published 2012-07-25
On 2012-07-25 the FDA classified a Class II recall of GE Healthcare Optima Mobile X-ray System by Ge Healthcare, citing 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 mandat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1993-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-04 |
| Published | 2012-07-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw |
|---|
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-1993-2012%22
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