BEUDAMED
    FDA Enforcement Class II Terminated

    Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

    Recall: Z-1690-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1690-2021
    Event ID
    87819
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 9, 2021
    Initiation Date
    April 16, 2021
    Classification Date
    May 28, 2021
    Termination Date
    February 6, 2024
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

    Reason

    Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

    Code Info

    All lots/serial numbers manufactured from 1/1/2019-3/31201

    Distribution

    US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.

    Quantity

    34 units