FDA Medical Device Recalls (openFDA)
GE OEC Medical Systems, Inc: OEC 9800. MDL Numbers: D222250, D141598
- Recall number
- Z-1059-2017
- Recalling firm
- GE OEC Medical Systems, Inc
- Product
- OEC 9800. MDL Numbers: D222250, D141598
- Status
- Terminated
- Initiated
- 2016-12-27
- Posted
- 2017-01-20
- Terminated
- 2018-07-12
- Reason
- GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
- Root cause
- Packaging change control
- Action
- The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned.
- Quantity
- 26,256 total
- Distribution
- Worldwide including govt/VA/military and foreign consignees.
- Lot, serial or model codes
- Manufactured from Feb 1998 to present
- 510(k) numbers
- ["K111551","K132027"]
- PMA numbers
- not on file
- Product code
- OWB
- 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