Recall Z-0041-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc.
| Date | Oct 25, 2006 (initiated Sep 13, 2006) |
| Status | Terminated |
| Reason | Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy. |
| Root cause | Other |
| Action | Consignees will be notified by letter beginning 10/16/2006. |
| Quantity | 40 units |
| Distribution | FL, GA, IL, IN, LA, MA, MD, MO, NH, NJ, PA, TX, UT. Includes one VA facility in PA. China, France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041931 | OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION Ge Oec Medical Systems, Inc., Aug 26, 2004 |