FDA Medical Device Recalls (openFDA)
Ge Healthcare: GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
- Recall number
- Z-0004-2010
- Recalling firm
- Ge Healthcare
- Product
- GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
- Status
- Terminated
- Initiated
- 2009-08-12
- Posted
- 2010-01-20
- Terminated
- 2012-04-23
- Reason
- A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- An Important Electronic Product Radiation Warning letter will be sent to customers identifying the issues, interim solution, and permanent solution. Questions or concerns are to be directed to the GEHC OEC service team at 1-800-874-7378.
- Quantity
- 1411 units total
- Distribution
- Nationwide and Canadian Distribution
- Lot, serial or model codes
- All associated serial numbers
- 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