FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies: Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136
- Recall number
- Z-0015-04
- Recalling firm
- GE Medical Systems Information Technologies
- Product
- Critikon brand Omni-Sat Adult, Semi-Disposable Sensor - P/N 009136
- Status
- Terminated
- Initiated
- 2000-11-16
- Posted
- 2003-10-15
- Terminated
- 2012-05-03
- Reason
- Instructions for use contained incorrect sensor reference.
- Root cause
- Other
- Action
- A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
- Quantity
- Total of 481
- Distribution
- Product was distributed to 69 domestic hospitals nationwide including four military accounts. Also product was distributed 6 accounts in Canada, one in Thailand, one in Chile, one in Japan and one in singapore.
- Lot, serial or model codes
- Lot 3910
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1030184
- Firm city
- Tampa
- Firm state
- FL
- 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