GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
FDA device recall Z-0368-2008 · posted 2008-09-29 · Terminated
Recall details
- Recalling firm
- OEC Medical Systems, Inc
- Reason for recall
- 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.
- Action taken
- GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 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 I
- Date initiated
- 2007-12-14
- Date posted
- 2008-09-29
- Date terminated
- 2012-04-13
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.