BEUDAMED
    FDA Enforcement Class II Ongoing

    Ascom Telligence Nurse Call System

    Recall: Z-0486-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0486-2019
    Event ID
    81546
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ascom (US) Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 28, 2018
    Initiation Date
    November 2, 2018
    Classification Date
    November 20, 2018
    Address
    9024 Town Center Parkway, N/A, Lakewood Ranch, FL, 34202-4159, United States

    Description

    Ascom Telligence Nurse Call System

    Reason

    There is an issue that could cause the Telligence System Gateway II, NGGTWY2 H, to stop communicating to the hallway devices connected to it. When this occurs, the dome lights connected to the Gateway II Ports A and B will start flashing, indicating that they are no longer communicating to the Gateway II. If this occurs, device failures that WOULD otherwise be annunciated WILL NOT be indicated at staff consoles that are configured to display failures.

    Code Info

    Version 5.0 (Build 5.0.4)

    Distribution

    AL, CA, CO, GA, IN, KY, LA, ME, MI, MO, MN, MS, NE, NV, OH, PA, RI, TX UT, VA, WI

    Quantity

    57 units