BEUDAMED
    FDA Enforcement Class I Terminated

    Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.

    Recall: Z-0749-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0749-2013
    Event ID
    63761
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    October 15, 2012
    Classification Date
    February 8, 2013
    Termination Date
    January 18, 2017
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.

    Reason

    Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

    Code Info

    Model M1139612

    Distribution

    Worldwide Distribution - Worldwide Distribution - USA including AL, AZ, CA, CO, FL,GA, IA, ID, IL, KY, MA, MD, MI, MN, MO, MS, MT, NC, ND ,NE, NM, NV, NY, OH, OR, PA ,TX, VT, WA, WI and WV; and the countries of Australia, Belgium, Canada, China, France, New Zealand, Poland, Saudi Arabia, Switzerland and United Kingdom.

    Quantity

    276 units total, 109 of those nationwide.