FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
- Recall number
- Z-0989-2007
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
- Status
- Terminated
- Initiated
- 2007-07-06
- Posted
- 2007-07-12
- Terminated
- 2013-02-01
- Reason
- The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
- Root cause
- Other
- Action
- Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available.
- Quantity
- 22 units
- Distribution
- Worldwide, including USA, France, Singapore, Sweden, and Switzerland.
- Lot, serial or model codes
- Serial numbers: E2-0083, E2-0096, E2-0100, E2-0122, E2-0139, E2-0141, E2-0144, E2-0153, E2-7040-MH, E2-7054-MH, E2-7062-MH, E2-7070-MH, E9-0012, E9-0029, E9-0059, E9-0085, E9-0106, E9-0114, E9-0170, ES-0052, ES-0159, ES-0171.
- 510(k) numbers
- K041931
- 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