BEUDAMED
    FDA Recall Terminated

    Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")

    Recall: Z-1006-2009 · Initiated December 15, 2008

    Recall

    Recall Number
    Z-1006-2009
    Event Number
    50146
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 15, 2008
    Posted
    March 9, 2009
    Terminated
    March 19, 2012
    Address
    8500 Sw Creekside Pl, Beaverton, OR, 97008

    Description

    Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED 10")

    Reason

    Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;

    Action

    Welch Allyn sent a Customer Recall Notice dated February 26, 2009, to all customers (customer list supplied by distributors). Welch Allyn will upgrade all units with software version 2.02 and lower to version 2.06.02 by Proc. AED10 Prod Service Min HW/SW Update Rev. E 820-0178-00.

    Distribution

    Worldwide Distribution.

    Quantity

    10, 735