FDANovember 25, 2024device
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
What to do
FDA enforcement status: Ongoing
Brands named
ge medical systems
UPCs
00840682115278
Recall history
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