TemporaryFDAOngoing
Can cause harm that is usually temporary.
Optima XR200amx, Mobile Digital-Ready Radiographic System
Check the device or its packaging for
UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
- Why
- 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.
- Distributed
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- Company
- GE Medical Systems, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2726-2026 · retrieved 13 July 2026
Read the official notice