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U.S. Department of Health and Human Services

Class 2 Device Recall OxiMax N560 Pulse Oximeter

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  Class 2 Device Recall OxiMax N560 Pulse Oximeter see related information
Date Initiated by Firm June 29, 2015
Date Posted July 27, 2015
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
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