Z-1049-04

Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5

Name: Z-1049-04 Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
Creator: Respironics Novametrix, Inc.
Published: 2002-09-02
License: https://open.fda.gov/license/

Respironics Novametrix, LLC. / initiated 2002-09-02 / Terminated

FDA source

Respironics Novametrix, Inc. began a recall of Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5 on 2002-09-02. The reason FDA records is "Audio alarm may fail to sound when SpO2 limits drop below the set limits". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1049-04
Status: Terminated
Initiated: 2002-09-02
Posted: 2004-07-20
Terminated: 2004-07-06
Recalling firm: Respironics Novametrix, LLC.
Product: Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
Product code: DQA Oximeter
Reason for recall: Audio alarm may fail to sound when SpO2 limits drop below the set limits
FDA root cause: Other
Action: Respironics notified customers by letter dated 9/3/02 of the problem with the failure of the audible alarm. A correction would require replacement of the speaker. Non-responders were recontacted by second letter on 2/24/2004.
Quantity in commerce: 901 units
Distribution: AK, AZ, CA, CT, FL, NY, NM, PA, OK, TX,
Product codes and lots: Software versions 2.0 or 2.5

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)