Medical Device Recall: Optima XR240amx, Mobile Digital Radiographic System
GE Medical Systems, LLC · June 5, 2026
Reason for Recall
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.
Distribution
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
States Affected
NATIONWIDE
Quantity Affected
24 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2728-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.