Recall Z-0368-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
OEC Medical Systems, Inc
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
| Date | Sep 29, 2008 (initiated Dec 14, 2007) |
| Status | Terminated |
| Reason | Possible overexposure: Failure to apply the entrance exposure rate (EER) tube current limit calibration to the automatic exposure rate (AER) control system when the anatomical profile mode is changed from the default selection to another selection. Manual technique modes are not affected. |
| Root cause | Software design |
| Action | GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation. |
| Quantity | 710 |
| Distribution | Worldwide distribution: USA, Finland, Netherlands, Germany, Switzerland, France, United Kingdom, Australia, Italy, Ireland, Spain, Sweden, Belgium, New Zealand, China, Singapore, Poland, Norway, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.