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 972200

    Recall: Z-1106-06 · Initiated June 15, 2006

    Recall

    Recall Number
    Z-1106-06
    Event Number
    35587
    Firm
    MRL, Inc., A Welch Allyn Company
    FEI Number
    1418729
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 15, 2006
    Posted
    June 22, 2006
    Terminated
    July 19, 2007
    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 972200

    Reason

    The Welch Allyn AED 20 Defibrillators 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 appropriate therapy.

    Action

    MRL issued a press release on 6/15/06, and began sending Urgent Medical Device Recall letters on the same date to the direct accounts informing them of the possibility of the defibrillator going into a terminal failure due to a U25 IC socket susceptible to defibrillation circuit board communication errors. The accounts were asked to respond to the notification witihin 5 working days by faxing or mailing the enclosed response form, or calling Welch Allyn-MRL Technical Support at 1-800-462-0777. A loaner AED 20 will then be sent to the consignee with instrucitons on how to return their unit for correction.

    Distribution

    Worldwide-including USA, Australia, Canada, China, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Nicaragua, Norway, Poland, Portugal, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, United Arab Emirates and the United Kingdom.

    Quantity

    580 units