Z-0664-05

Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare...

Name: Z-0664-05 Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare...
Creator: Nellcor Puritan Bennett
Published: 2004-10-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-10-18 / Terminated

FDA source

Nellcor Puritan Bennett began a recall of Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton... on 2004-10-18. The reason FDA records is "The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0664-05
Status: Terminated
Initiated: 2004-10-18
Posted: 2005-03-30
Terminated: 2006-05-15
Recalling firm: Medtronic, Inc.
Product: Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.
Product code: DQA Oximeter
Reason for recall: The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
FDA root cause: Other
Action: Customers of record were notified of the advisory by letter sent via US Mail on October 18, 2004, via certified mail. A second letter was sent on December 9, 2004, advising customers that upgrades would be available. Upgrades would be available via returns to the firm''s service center, upgrade kits and speaker replacements via self-installation, and a third party service provider.
Quantity in commerce: 42,451 units
Distribution: There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
Product codes and lots: All units with serial numbers beginning with G01844386.

Product code DQA

K012891Class IIOximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories)Nellcor Puritan Bennett, Inc. / cleared 2002-03-07

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)