FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.
- Recall number
- Z-1302-06
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.
- Status
- Terminated
- Initiated
- 2006-08-16
- Posted
- 2006-09-30
- Terminated
- 2011-07-27
- Reason
- X-ray systems could provide output which exceeds the 20 R/minute limit.
- Root cause
- Other
- Action
- Consignees were notified by certified letter on 08/14-15/2006.
- Quantity
- 8,266 units (US), 2,664 units (foreign)
- Distribution
- Worldwide
- Lot, serial or model codes
- All units
- 510(k) numbers
- ["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