Optima XR220amx, 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 XR220amx, 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: 00840682115261Model System IDs: 05249MOB02.OLDModel 205820DP1Model 228818XR220Model 229276M1Model 240566P1Model 301295OPTIMA2Model 303788SBOPT1Model 314251P5Model 352LEEDP1Model 386FLGDPXR3Model 417347DPORT1Model 512SAMCSBModel 516632OPTIMA2Model 540981ODP7Model 563264OPTModel 601445DP1Model 615338HDP01Model 661949DP2Model 713441OPCDX1Model 717657OPT1Model 718206OPT240AModel 727848SB1Model 732321DP1Model 757736DP3UPC 00840682115261Would you have heard about this one?
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