BEUDAMED
    FDA Enforcement Class I Terminated

    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

    Recall: Z-1440-2014 · Reported April 16, 2014

    Enforcement

    Recall Number
    Z-1440-2014
    Event ID
    67677
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 16, 2014
    Initiation Date
    March 5, 2014
    Classification Date
    April 10, 2014
    Termination Date
    October 31, 2014
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833

    Reason

    The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.

    Code Info

    Oxylog 3000 plus, Part number: 5704833 with serial numbers: ASEK-0003, ASEK-0004, ASEK-0005

    Distribution

    USA Nationwide Distribution in the states of WI and NY.

    Quantity

    3