GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
This recall has been terminated (originally issued September 29, 2008).
- Company
- Oec Medical Systems, Inc
- Recall Initiated
- December 14, 2007
- Posted
- September 29, 2008
- Terminated
- April 13, 2012
- Recall Number
- Z-0368-2008
- Quantity
- 710
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All codes
Root Cause
Software design
Action Taken
GE OEC sent a letter to customers December 15, 2007, and scheduled field representative visits for corrective software solution installation.