Optima XR200amx Radiographic System
GE HealthCare recalls Optima XR200/220/240amx systems after column replacement due to risk of arm drop and patient injury.
Contact your GE HealthCare representative immediately to schedule a functional test of the safety pawl and ensure proper assembly. Do not use the system until the test has been completed.
Why it was recalled
GE HealthCare is recalling certain Optima XR200/220/240amx systems that have had a column replacement completed, because functional testing of the safety pawl may not have been performed. If the internal counterpoise cable fails, the column safety mechanism may not work, causing the arm with the X-ray tube and collimator to drop and potentially injure a patient during an exam.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| Optima XR200amx, Mobile Digital-Ready Radiographic System | Z-2726-2026 | 00840682115278 |
| Optima XR220amx, Mobile Digital-Ready Radiographic System | Z-2727-2026 | 00840682115261, 850070941 |
| Optima XR240amx, Mobile Digital Radiographic System | Z-2728-2026 | 00840682122351, 00840682123686 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from GE Medical Systems, LLC
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification