FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
- Recall number
- Z-0677-2007
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
- Status
- Terminated
- Initiated
- 2007-03-01
- Posted
- 2007-09-28
- Terminated
- 2012-05-01
- Reason
- During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Root cause
- Other
- Action
- Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.
- Quantity
- 1857 units
- Distribution
- Nationwide and Germany.
- Lot, serial or model codes
- Serial Numbers: 429 units within the range 8S-0007 thru 8S-7163, 455 units within the range 89-0014 thru 89-3520, 659 units within the range 82-0010 thru 82-7138.
- 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