BEUDAMED
    FDA Enforcement Class II Terminated

    Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.

    Recall: Z-1499-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1499-2017
    Event ID
    76047
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanley Security Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    June 22, 2016
    Classification Date
    March 20, 2017
    Termination Date
    November 20, 2017
    Address
    4600 Vine St, Lincoln, NE, 68503-2823, United States

    Description

    Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.

    Reason

    Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.

    Code Info

    Serial numbers WP149149 through WP149398 and WP149649 through WP149898.

    Distribution

    Nationwide Distribution to AR, AZ, CA, FL, GA, IA, ID, IN, KS, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SD, UT, VA, and WI.

    Quantity

    500 individual pendants