BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1389-2009 · Initiated February 26, 2009

    Recall

    Recall Number
    Z-1389-2009
    Event Number
    51496
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 26, 2009
    Posted
    June 23, 2009
    Terminated
    March 7, 2012
    Address
    8500 Sw Creekside Pl, Beaverton, OR, 97008

    Description

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

    Reason

    Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.

    Action

    Welch Allyn sent an Urgent Medical Device Recall letter dated February 26, 2009 to all distributors and customers, describing 5 failure modes. Customers were instructed to respond to the letter by calling 888-345-5356, and decide on replacement or discounted new purchase.

    Distribution

    Worldwide distribution.

    Quantity

    Issue #1: 4568 units; Issue#2: 5186 units