BEUDAMED
    FDA Recall Terminated

    Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.

    Recall: Z-0160-2011 · Initiated June 25, 2010

    Recall

    Recall Number
    Z-0160-2011
    Event Number
    56148
    Firm
    Edwards Lifesciences, Llc
    FEI Number
    2015691
    Product Code
    DXG
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 25, 2010
    Posted
    October 28, 2010
    Terminated
    May 24, 2011
    Address
    1 Edwards Way, Irvine, CA, 92614-5688

    Description

    Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.

    Reason

    The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.

    Action

    Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007.

    Distribution

    Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand

    Quantity

    20 units