BEUDAMED
    FDA Enforcement Class II Ongoing

    Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.

    Recall: Z-1250-2023 · Reported March 22, 2023

    Enforcement

    Recall Number
    Z-1250-2023
    Event ID
    91625
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Securitas Healthcare LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2023
    Initiation Date
    February 6, 2023
    Classification Date
    March 14, 2023
    Address
    4600 Vine St, N/A, Lincoln, NE, 68503-2823, United States

    Description

    Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.

    Reason

    The mobile application for Android devices downloaded from the Google Play Store do not load per specifications and function on the Android devices.

    Code Info

    v11.0.0.2 downloaded from the Google Play Store on or after 1/14/2023, UDI (01)00840948102769(10)110026.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    Approximately 350 downloads