Product Wiki · Recalls · U.S. FDA — Device Enforcement

OxiMax N-560 Pulse Oximeter — recall Z-2268-2015

U.S. FDA — Device Enforcement · United States · 2015-06-29 · Class II

As described by U.S. FDA — Device Enforcement: OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2268-2015
Date of alert
2015-06-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide including Canada.
Reported risk: Potential missing segments on the display that can result in misinterpretation of data.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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