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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Nonin Cerebral Oximeter Pod		see related information
Date Posted November 25, 2009
Recall Number Z-0458-2010
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, Minnesota 55441
Consumer Instructions Contact the recalling firm for information
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.
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.
 
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