FDA-Device2025-01-15Class II
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
GE Medical Systems, LLC
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.
Sold states
Worldwide
Affected count
281 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0812-2025Don't want to check this manually?
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