Z-0014-04

Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130

Name: Z-0014-04 Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
Creator: GE Medical Systems Information Technologies
Published: 2000-11-16
License: https://open.fda.gov/license/

GE Medical Systems Information Technologies, Inc. / initiated 2000-11-16 / Terminated / root cause: labeling and UDI

FDA source

GE Medical Systems Information Technologies began a recall of Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130 on 2000-11-16. The reason FDA records is "Instructions for use contained incorrect sensor reference". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0014-04
Status: Terminated
Initiated: 2000-11-16
Posted: 2003-10-15
Terminated: 2012-05-03
Recalling firm: GE Medical Systems Information Technologies, Inc.
Product: Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
Reason for recall: Instructions for use contained incorrect sensor reference.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot numbers 008 and 005

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)