BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1007-2009 · Initiated December 15, 2008

    Recall

    Recall Number
    Z-1007-2009
    Event Number
    50532
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 15, 2008
    Posted
    March 10, 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

    Potential for device to deliver less than the programmed energy.

    Action

    Welch Allyn notified distributors by letter on 12/15/2008 requesting that they notify their customers. Welch Allyn sent an Urgent: Medical Device Recall letter to distributors and customers on February 26, 2009.

    Distribution

    Worldwide distribution.

    Quantity

    14,012 devices