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U.S. Department of Health and Human Services

Class 2 Device Recall Nonin Cerebral Oximeter Pod

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  Class 2 Device Recall Nonin Cerebral Oximeter Pod see related information
Date Initiated by Firm October 23, 2009
Date Posted November 25, 2009
Recall Status1 Terminated 3 on March 29, 2012
Recall Number Z-0458-2010
Recall Event ID 53801
510(K)Number K090807  
Product Classification Tissue Saturation Oximeter - Product Code MUD
Product Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Nonin Medical, Inc., 13700 First Avenue North, Plymouth, Minnesota 55441-5443 USA.
Code Information Serial numbers: 500814470, 500814472, 500814474, 500814478, 500814480, 500814484, 500823139, 500823145, 500823146, 500823154, 500823159, 500823161, 500823164, 500823166, 500823172, 500823174, 500823175, 500823176, 500823181, 500823182, 500849316, 500849318, 500849321, 500849325, 500849331, 500849333, 500849336, 500849337, 500849338, 500849342, 500849343, 500849344, 500849347, 500849348, 500849349, 500849350, 500849351, 500849353, 500849356, 500849357, 500849358, 500849360, 500849361, 500849366, 500849367, 500849368, 500849369, 500849370, 500849372, 500849373, 500849375, 500849378, 500849380, 500849386, 500849387, 500849388, 500849389, 500849390, 500857060, 500857061, 500857064, and 500874926.
Recalling Firm/
Manufacturer		 Nonin Medical, Inc
13700 1st Ave N
Plymouth MN 55441
For Additional Information Contact
763-553-9968
Manufacturer Reason
for Recall		 A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.
FDA Determined
Cause 2		 Device Design
Action An Urgent: Medical Device Recall letter was emailed to customers on 10/23/2009. The letter described the issue and hazard and asked that the use of the device be discontinued and to immediately contact Nonin for return and repair/replacement instructions. Questions or concerns should be directed to John Dalpee at 763-577-3166.
Quantity in Commerce 62
Distribution Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom.
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 = MUD and Original Applicant = NONIN MEDICAL, INC.
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