Recall Z-0042-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.
| Date | Oct 14, 2006 (initiated Sep 30, 2006) |
| Status | Terminated |
| Reason | X-ray system may lose or mix images and/or lose patient data. |
| Root cause | Other |
| Action | Consignees will be notified by letter beginning 10/21/2006. |
| Quantity | 822 units |
| Distribution | Nationwide, including VA facilities in FL, NC, WA and military accounts in GA and WA. Foreign distribution to Australia, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK. |
| 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 |