FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC 9800 Plus Fluoroscopic X-ray System
- Recall number
- Z-0558-2007
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC 9800 Plus Fluoroscopic X-ray System,
- Status
- Terminated
- Initiated
- 2007-02-09
- Posted
- 2007-03-22
- Terminated
- 2007-06-26
- Reason
- During routine service, a cover may have been installed without the required proper lead shielding.
- Root cause
- Other
- Action
- Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
- Quantity
- 11 units of all models
- Distribution
- Nationwide to AL, AZ, IA, OH, TX, VA, and WV.
- Lot, serial or model codes
- Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.
- 510(k) numbers
- ["K021049","K022069","K024012"]
- 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