BEUDAMED
    FDA Enforcement Class II Terminated

    STANLEY Healthcare Arial 54315 Network Manager

    Recall: Z-1996-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-1996-2019
    Event ID
    83266
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanley Security Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 31, 2019
    Initiation Date
    June 14, 2019
    Classification Date
    July 19, 2019
    Termination Date
    May 13, 2021
    Address
    4600 Vine St, N/A, Lincoln, NE, 68503-2823, United States

    Description

    STANLEY Healthcare Arial 54315 Network Manager

    Reason

    STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial¿ 54315 Serial-to-IP Network Gateway.

    Code Info

    Serial Numbers: 0008DC517FD2, 0008DC517FD3, 0008DC517FD4, 0008DC517FD5, 0008DC517FD6, 0008DC517FD7, 0008DC517FD8, 0008DC517FD9, 0008DC517FDA, 0008DC517FDB, 0008DC517FDC, 0008DC517FDD, 0008DC517FDE, 0008DC517FDF, 0008DC517FE0, 0008DC517FE1, 0008DC517FE2, 0008DC517FE3, 0008DC517FE4, 0008DC517FE5, 0008DC51807D, 0008DC51807E, 0008DC51807F, 0008DC518080, 0008DC518081, 0008DC518082, 0008DC518083, 0008DC518084, 0008DC518085, 0008DC518086, 0008DC56ECDA, 0008DC56ECDB, 0008DC56ECDC, 0008DC56ECDD, 0008DC56ECE1, 0008DC56ED32, 0008DC56ED33, 0008DC56ED37, 0008DC56ED38, 0008DC56ED39, 0008DC56ED3A, 0008DC56ED3B, 0008DC56ED3C, 0008DC56ED3D, 0008DC56ED56, 0008DC56ED57, 0008DC56ED58, 0008DC56ED5A, 0008DC56ED5B, 0008DC56ED5D, 0008DC56ED5F, 0008DC56ED60, 0008DC56ED61, 0008DC56ED66, 0008DC56ED67, 0008DC56ED68, 0008DC56ED69, 0008DC56ED6D, 0008DC56ED72, 0008DC56ED76, 0008DC56ED77, 0008DC56ED78, 0008DC56ED7A, 0008DC56ED7B, 0008DC56ED7C, 0008DC56ED7D, 0008DC56ED80, 0008DC56ED81, 0008DC56ED82, 0008DC56ED83, 0008DC56ED84, 0008DC56ED85, 0008DC56ED86, 0008DC56ED87, 0008DC56ED88, 0008DC56ED89, 0008DC56ED8A, 0008DC56ED8B, 0008DC56ED8C, 0008DC56ED8E, 0008DC56ED8F, 0008DC56ED90, 0008DC56ED91, 0008DC56ED92, 0008DC56ED93, 0008DC56ED94, 0008DC56ED98, 0008DC56ED99, 0008DC56ED9A, 0008DC56ED9E, 0008DC56EDA0, 0008DC56EDA1, 0008DC56EE26, 0008DC56EE2A, 0008DC56EE42, 0008DC56EE43, 0008DC56EE44, 0008DC56EE45, 0008DC56EE49, 0008DC56EE4A, 0008DC56EE4B, 0008DC56EE4E, 0008DC56EE4F, 0008DC56EE50, 0008DC56EE51, 0008DC56EE52, 0008DC56EE53, 0008DC56EE54, 0008DC56EE55, 0008DC56EE5A, 0008DC56EE5B, 0008DC56EE5C, 0008DC56EE60, 0008DC56EE61, 0008DC56EE6A, 0008DC56EE6B, 0008DC56EE6C, 0008DC56EE6E, 0008DC56EE6F, 0008DC56EE70, 0008DC56EE71, 0008DC56EE72, 0008DC56EE73, 0008DC56EE74, 0008DC56EE75, 0008DC56EE76, 0008DC56EE77, 0008DC56EE78, 0008DC56EE79, 0008DC56EE7A, 0008DC56EE7C, 0008DC56EE7D, 0008DC56EE7E, 0008DC56EE7F, 0008DC56EE80, 0008DC56EE81, 0008DC56EE82

    Distribution

    Nationwide and Canada

    Quantity

    137 units