Optima XR200amx, Mobile Digital-Ready Radiographic System
GE Medical Systems, LLC
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Optima XR200amx, Mobile Digital-Ready Radiographic System
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 00840682115278Model System IDs: 419383DP3Model 773792XR200Model 856355OPTModel FEB520100UPC 00840682115278Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.