BEUDAMED
    FDA Recall Terminated

    HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.

    Recall: Z-1316-2018 · Initiated November 13, 2017

    Recall

    Recall Number
    Z-1316-2018
    Event Number
    79010
    Firm
    Lifeline Systems Company
    FEI Number
    1000086682
    Product Code
    ILQ
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    November 13, 2017
    Terminated
    May 16, 2019
    Address
    111 Lawrence St, Framingham, MA, 01702-8156

    Description

    HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.

    Reason

    A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.

    Action

    Firm has contacted all recipients and informed them of an issue that affects Philips Lifeline AutoAlert help button from automatically signaling the Lifeline Response Center for help in the event of a fall. Further instructed them that they would need to press the Lifeline Help Button in order to connect with the emergency response center. They then instruct them to return their inventory for replacement. New AAHB Replacements will be provided when available. Philips will work with the Programs to ensure buttons swaps are completed.

    Distribution

    US and Canada distribution

    Quantity

    20201