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Recall

GE Medical Systems, LLC: Optima XR200amx, Mobile Digital-Ready Radiographic System Recall

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. Product details: Optima XR200amx, Mobile Digital-Ready Radiographic System

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Agency
FDA
Record ID
Z-2726-2026
Canonical
https://claimwatch-mvp.vercel.app/item/ge-medical-systems-llc-optima-xr200amx-mobile-digital-ready-radiographic-system/

What happened?

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. Product details: Optima XR200amx, Mobile Digital-Ready Radiographic System

Who may be affected?

Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.

What should consumers do?

Affected quantity: 4 units

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