BEUDAMED
    FDA Enforcement Class I Terminated

    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

    Recall: Z-0692-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0692-2016
    Event ID
    72914
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2016
    Initiation Date
    December 22, 2015
    Classification Date
    February 3, 2016
    Termination Date
    April 5, 2017
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

    Reason

    Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.

    Code Info

    All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.

    Distribution

    Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

    Quantity

    402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus)