BEUDAMED
    FDA Enforcement Class II Ongoing

    The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

    Recall: Z-0258-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0258-2020
    Event ID
    83889
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draegar Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2019
    Initiation Date
    September 13, 2019
    Classification Date
    October 31, 2019
    Address
    6 Tech Dr, Andover, MA, 01810-2434, United States

    Description

    The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

    Reason

    Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

    Code Info

    Software version VG4.1.1/VG4.0.3 and lower

    Distribution

    US Nationwide distribution.

    Quantity

    5634