BEUDAMED
    FDA Enforcement Class II Terminated

    Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    Recall: Z-2491-2012 · Reported October 10, 2012

    Enforcement

    Recall Number
    Z-2491-2012
    Event ID
    61796
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanley Security Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 10, 2012
    Initiation Date
    May 4, 2012
    Classification Date
    September 28, 2012
    Termination Date
    September 24, 2013
    Address
    4600 Vine St, N/A, Lincoln, NE, 68503-2823, United States

    Description

    Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.

    Reason

    The monitor may fail to sound an alarm

    Code Info

    Serial numbers 228837 thru 268768

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada and Great Britain.

    Quantity

    4,148 units