FDA issues recall of portable imaging systems

Certain portable imaging equipment manufactured by GE HealthCare is being recalled due to potential risk of patient harm. 

According to the U.S. Food and Drug Administration’s registry of active medical device recalls, GE’s Optima XR Mobile Digital-Ready Radiographic systems are being voluntarily recalled due to a process control issue. The notice indicates that systems that have had column replacements might not function appropriately. 

“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,” the notice reads. “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.” 

GE issued urgent medical device correction letters to affected customers in late June. Those messages suggest that the equipment can still be safely used, but that users should watch for specific behaviors that could indicate the equipment has been impacted by the issue. Specifically, if the column requires increased effort to move vertically, has a change in resistance or makes abnormal noises during vertical movement, the system likely needs a repair. If these behaviors are noticed, the equipment should be sidelined and users should contact their GE service representative. 

The Class 2 recall applies to less than 100 units that are in distribution globally, including in the U.S. There have been no injuries related to the issue reported thus far. 

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