FDA Medical Device Recalls (openFDA)
OEC Medical Systems, Inc: GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
- Recall number
- Z-0368-2008
- Recalling firm
- OEC Medical Systems, Inc
- Product
- GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
- Status
- Terminated
- Initiated
- 2007-12-14
- Posted
- 2008-09-29
- Terminated
- 2012-04-13
- 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.
- Lot, serial or model codes
- All codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1720753
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28