Ge Medical Systems, Llc: System, X-ray, Mobile
Summary GE HealthCare is recalling certain Optima XR200/220/240amx mobile X-ray systems because safety testing may have been skipped after column replacements, potentially allowing the X-ray arm to drop during use if an internal cable fails. This could injure patients during imaging procedures. The recall affects systems distributed across the US, Canada, Brazil, Mexico, and several other countries.
- Recalling firm
- GE Medical Systems, LLC
- Product
- 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.
- 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/9b2d031c-e91f-44e9-95ec-358ae2851661