BEUDAMED
    FDA Enforcement Class II Ongoing

    Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application

    Recall: Z-0570-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0570-2025
    Event ID
    95652
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Securitas Healthcare LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    November 1, 2024
    Classification Date
    November 27, 2024
    Address
    4600 Vine St, Lincoln, NE, 68503-2823, United States

    Description

    Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application

    Reason

    Certain software versions will not notify end users of calls initiated by call points with the Arial Emergency and Nurse Call System.

    Code Info

    All Systems using Arial Server Software versions 11.1.4 through 11.1.6 in conjunction with the Arial Mobile Application or Arial Care Giver Application

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Switzerland.

    Quantity

    111 systems