Optima XR240amx, Mobile Digital 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 XR240amx, Mobile Digital 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: 00840682122351 and 00840682123686Model System IDs: 252847PP249Model 281MSL2402Model 291OPTI1Model 312CCHSUPER7Model 318487OPTIMA1Model 360744OPT2402Model 501686OPTI1Model 504826XR241Model 519941XR240AModel 540776ODP3Model 541472M4Model 602344240CModel 706291BEE9Model 713799XR240Model 770836BEE2Model 813872OPT11Model 813872OPT9Model 843724OPT1Model 843847OPT240Model 870239OPT2Model 905522AMX240Model 973625DIG4Model DF2402001002WKModel SA1013MM13UPC 00840682122351UPC 00840682123686Would you have heard about this one?
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