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GE Medical Systems, LLC recalls GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3
Recalled January 15, 2025 · FDA recall Z-0813-2025 · GE Medical Systems
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. · FDA Class II
Units
120 units
Sold at
Worldwide
Description
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.
Product
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →