Recall Z-0848-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
| Date | Jun 30, 2007 (initiated Jun 12, 2007) |
| Status | Terminated |
| Reason | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
| Root cause | Other |
| Action | 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. |
| Quantity | 295 units |
| Distribution | Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the 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 |