BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0458-2010 · Initiated October 23, 2009

    Recall

    Recall Number
    Z-0458-2010
    Event Number
    53801
    Firm
    Nonin Medical, Inc
    FEI Number
    2183646
    Product Code
    MUD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 23, 2009
    Posted
    November 25, 2009
    Terminated
    March 29, 2012
    Address
    13700 1st Ave N, Plymouth, MN, 55441

    Description

    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.

    Reason

    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.

    Distribution

    Worldwide Distribution -- USA, including states of LA, MN, NC, and NY and countries of Canada, Germany, Italy, Netherlands, and United Kingdom.

    Quantity

    62