Ge Medical Systems, Llc: System, X-ray, Mobile
Recall Summary GE HealthCare is recalling certain Optima XR200/220/240amx mobile X-ray systems that have undergone column replacement, because safety testing may not have been completed after the repair. If an internal cable fails, the arm holding the X-ray tube could drop unexpectedly, potentially injuring patients during imaging procedures. The recall affects systems distributed nationwide and in several other countries.
- Recalling firm
- GE Medical Systems, LLC
- Product
- Optima XR220amx, 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e203ac59-3224-45aa-99c9-185542d92c0f