Z-2267-2015Class II

OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of...

Name: Z-2267-2015 OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of...
Creator: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Published: 2015-06-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-06-29 / Terminated / root cause: design

FDA source

Covidien LP (formerly Nellcor Puritan Bennett Inc.) began a recall of OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and... on 2015-06-29. FDA classified it as Class II and gives the reason as "Potential missing segments on the display that can result in misinterpretation of data". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2267-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-29
Posted: 2015-07-27
Terminated: 2017-11-03
Recalling firm: Medtronic, Inc.
Product: OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Product code: DQA Oximeter
Reason for recall: Potential missing segments on the display that can result in misinterpretation of data.
Root cause tag: design
FDA root cause: Device Design
Action: Metronic sent an Urgent Medical Device Correction letter dated June 29, 2015 to affected customers. The letter identified the adfected product, problem and actions to be taked. Customers where instructed to return the attached verification form. For questions contact your Medtronic representative.
Quantity in commerce: 211,426 units
Distribution: Worldwide Distribution - US Nationwide including Canada.
Product codes and lots: All Lots of Product Code N650, N65, N65-1, N65P, N65P-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2267-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2267-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-27
Z-2268-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-05	2015-07-27

Product code DQA

K123581Class IINellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring System, Nellcor Bedside Spo2 PatienCovidien, Formerly Nellcor Puritan Bennett, Inc. / cleared 2013-05-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)