BEUDAMED
    FDA Enforcement Class II Ongoing

    Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

    Recall: Z-0372-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0372-2020
    Event ID
    84028
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draegar Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    October 9, 2019
    Classification Date
    November 14, 2019
    Address
    6 Tech Dr, N/A, Andover, MA, 01810-2434, United States

    Description

    Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

    Reason

    The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

    Code Info

    All systems using Software version VG2.3.1 and lower

    Distribution

    US nationwide distribution.

    Quantity

    12204