GE Healthcare has identified a potential safety issue affecting four of its imaging systems and has issued an urgent recall notice to facilities that have one or more of the potentially faulty products. GE Healthcare has identified a potential safety issue affecting four of its imaging systems and issued an urgent recall notice on 9 February to facilities that have one or more of the following products:

• OEC® 9800


• OEC® FluoroTrak 9800 Plus


• OEC® 9800 Plus


• OEC® 9800MD Motorized C-arm System

Radiology managers are being warned that the systems listed above that have the following serial numbers: 89-1685, 89-2907, 89-2877, 89-2383, 89-3330, 82-7059-MH, 89-0247-RC, 89-0599, 89-2987, 89-1001 and 89-0972.

According to GEHC, the affected systems had the camera cover on the Image Intensifier replaced during a service call. The camera shield that was placed onto the system during this service call may not have the protective lead barrier as required. The lack of lead shielding may result in excessive scatter radiation exposure to the user and patient and is non compliant with CFR 21 Sec. 1020.32.

At this time users are advised to stop using the products with the corresponding serial numbers until the camera cover and shields are inspected and replaced if necessary.

The recall is not the first to be issued this year. In January 2007 GE announced that the company entered into a Consent Decree of Injunction with the US Food and Drug Administration (FDA) regarding GE OEC’s surgical imaging products and the OEC facilities in Salt Lake City, Utah, and Lawrence, Massachusetts.