GE Medical Systems, LLC: Optima XR200amx, Mobile Digital-Ready Radiographic System
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE Medical Systems, LLC
- Product
- Optima XR200amx, Mobile Digital-Ready Radiographic System
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.
- Recall initiated
- 2026-06-05
- Code info
- UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100
- Product quantity
- 4 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukesha
- State
- WI
- Country
- United States
- Event id
- 99279
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