GE Medical Systems, LLC — Optima XR200amx, Mobile Digital-Ready Radiographic System
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 5, 2026
Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
What's affected?
- Product
- Optima XR200amx, Mobile Digital-Ready Radiographic System
- Lot code
- UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
Additional details
UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4 units.
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