GE HealthCare issues recall of C-arms due to missing shielding components

GE HealthCare has issued a voluntary recall of some of its C-arm fluoroscopy systems due to concerns about the devices’ shielding components. 

On Aug. 22, the health tech giant’s OEC 9800 and OEC 9900 Elite C-arm Systems appeared on the U.S. Food and Drug Administration’s Medical Device Recall list. The Class 2 recall pertains to the system's built-in shielding and collimation accessories. 

“GE HealthCare has become aware of a nonconformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user,” the notification reads. 

The recall falls under the Radiation Control for Health and Safety Act due to concerns about the potential for excess radiation exposure. However, GE has not indicated there have been any reports from users related to high dosimetry readings. 

To address the issue, GE is sending affected customer letters detailing mitigation measures their staff can use to reduce the associated risks in the interim. The company says it will send qualified representatives to the affected units to inspect them and, if necessary, replace the collimator covers with the appropriate versions in noncompliant systems. This will come at no extra cost to customers. 

For more information, visit the FDA’s medical device recall hub here.