BEUDAMED
    FDA Enforcement Class II Ongoing

    Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.

    Recall: Z-0974-2019 · Reported March 13, 2019

    Enforcement

    Recall Number
    Z-0974-2019
    Event ID
    82014
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draegar Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2019
    Initiation Date
    February 8, 2019
    Classification Date
    March 5, 2019
    Address
    6 Tech Dr, N/A, Andover, MA, 01810-2434, United States

    Description

    Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.

    Reason

    The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.

    Code Info

    All software versions, all serial numbers.

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    10699 in total