Class 2 Device Recall OxiMax N560 Pulse Oximeter

• Date Initiated by Firm: June 29, 2015
• Date Posted: July 27, 2015
• Recall Status: Terminated on November 03, 2017
• Recall Number: Z-2268-2015
• Recall Event ID: 71583
• 510(K)Number: K123581
• Product Classification: Oximeter - Product Code DQA
• Product: OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
• Code Information: All Lots, Product code N560
• Recalling Firm/ Manufacturer: Covidien LP (formerly Nellcor Puritan Bennett Inc.); 6135 Gunbarrel Ave; Boulder CO 80301-3214
• For Additional Information Contact: Michael A. Ronningen; 303-530-6100
• Manufacturer Reason for Recall: Potential missing segments on the display that can result in misinterpretation of data.
• FDA Determined 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: 105,831 units
• Distribution: Worldwide Distribution - US Nationwide including Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQA