GE OEC Medical Systems, Inc GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

Recommended Action

Per FDA guidance

Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.

Distribution

As reported by FDA

CO, FL, GA, MD, PA, VA, WA