Optima XR200amx recall (GE Medical Systems, LLC)
Medical deviceClass IIOngoing
Summary: GE Medical Systems, LLC is recalling 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.
What is being recalled
Optima XR200amx, Mobile Digital-Ready Radiographic System
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
How to tell if yours is affected
UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2726-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 5, 2026 |
| Reported | July 22, 2026 |
| Company | GE Medical Systems, LLC |
| Company location | Waukesha, WI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 4 units |
More recalls from GE Medical Systems, LLC · all medical device recalls · recalls from June 2026