Class II

Medical Device Recall: Optima XR200amx, Mobile Digital-Ready 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

4 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2726-2026

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.