Z-0610-03

Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)

Name: Z-0610-03 Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
Creator: Datex-Ohmeda
Published: 2002-09-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2002-09-16 / Terminated

FDA source

Datex-Ohmeda began a recall of Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT) on 2002-09-16. The reason FDA records is "Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0610-03
Status: Terminated
Initiated: 2002-09-16
Posted: 2003-03-05
Terminated: 2004-07-02
Recalling firm: GE Healthcare
Product: Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT)
Product code: DQA Oximeter
Reason for recall: Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.
FDA root cause: Other
Action: 'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.
Quantity in commerce: 1019
Distribution: Nationwide in the United States and worldwide.
Product codes and lots: All serial numbers of the units distributed prior to the recall. September 16, 2002

Product code DQA

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)