BEUDAMED
    FDA Recall Terminated

    Philips Avalon Fetal Monitor FM20; Model Number: M2702A.

    Recall: Z-1478-2009 · Initiated May 12, 2009

    Recall

    Recall Number
    Z-1478-2009
    Event Number
    52026
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    HGM
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    May 12, 2009
    Posted
    June 26, 2009
    Terminated
    September 23, 2020
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Avalon Fetal Monitor FM20; Model Number: M2702A.

    Reason

    Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions

    Action

    Philips Healthcare issued an "Urgent-Medical Device Correction" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade. Questions can be made to Philips response center at 1-800-722-9377.

    Distribution

    Worldwide Distribution

    Quantity

    5,663 units