BEUDAMED
    FDA Enforcement Class II Terminated

    8500M Handheld Pulse Oximeter

    Recall: Z-1690-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1690-2017
    Event ID
    75424
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nonin Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2017
    Initiation Date
    September 29, 2016
    Classification Date
    March 28, 2017
    Termination Date
    March 12, 2018
    Address
    13700 1st Ave N, Plymouth, MN, 55441-4595, United States

    Description

    8500M Handheld Pulse Oximeter

    Reason

    Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.

    Code Info

    502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090

    Distribution

    Distribution in US (MI, NC, OH, NC, VA), and CANADA

    Quantity

    15 (11 US; 4 OUS)