BEUDAMED
    FDA Recall Terminated

    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E

    Recall: Z-0806-05 · Initiated April 28, 2005

    Recall

    Recall Number
    Z-0806-05
    Event Number
    31934
    Firm
    MRL, Inc., A Welch Allyn Company
    FEI Number
    1418729
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 28, 2005
    Posted
    May 12, 2005
    Terminated
    September 1, 2006
    Address
    1000 Asbury Dr, Ste 17, Buffalo Grove, IL, 60089-4551

    Description

    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part number 972200E

    Reason

    The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.

    Action

    Urgent Medical Device Recall letters dated 04/28/2005 were sent to the direct accounts informing them of the possibility in a terminal failure due to the radio frequency interference generated inside the AED 20 resulting from an intermittent electrical short. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.

    Distribution

    Nationwide and internationally to Australia, Canada, China, France, Germany, Ireland, Israel, Malaysia, the Middle East, New Zealand, the Philippines, Poland, Singapore, South America, South Korea, Switzerland and the United Kingdom.

    Quantity

    597