BEUDAMED
    FDA Recall Terminated

    Welch Allyn AED 10 Automated External Defibrillator

    Recall: Z-1005-2009 · Initiated December 15, 2008

    Recall

    Recall Number
    Z-1005-2009
    Event Number
    50142
    Firm
    Welch Allyn Protocol, Inc
    FEI Number
    3023750
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 15, 2008
    Posted
    March 10, 2009
    Terminated
    February 15, 2012
    Address
    8500 Sw Creekside Pl, Beaverton, OR, 97008

    Description

    Welch Allyn AED 10 Automated External Defibrillator

    Reason

    Potential for device to shut down prematurely under certain circumstances.

    Action

    On 4/13/07 the firm released Service Bulletin part no. 810-2614-00, SB - AED 10 S/W V020600 DOWNGRADE to V020500. That mandatory bulletin, for units with software version 2.06.00 and up indicates that all returning AED 10 units shall have their software version downgraded to 2.05.00.

    Distribution

    Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.

    Quantity

    89 units