FDA Device recall Z-2726-2026
Optima XR200amx, Mobile Digital-Ready Radiographic System
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Optima XR200amx, Mobile Digital-Ready Radiographic System by Ge Medical Systems, citing GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have bee….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2726-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-05 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
Optima XR200amx, Mobile Digital-Ready Radiographic System
Reason
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
Identifiers
| code_info | UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2726-2026%22
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