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Medical Device

Optima XR220amx, Mobile Digital-Ready Radiographic System

Recall date: 2026-07-22 · Source: FDA_DEVICE
Brand / Firm
GE Medical Systems, LLC
Product
Optima XR220amx, Mobile Digital-Ready Radiographic System
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.
Units affected
38 units
Description
Optima XR220amx, Mobile Digital-Ready Radiographic System
View official recall notice →