BEUDAMED
    FDA Enforcement Class II Ongoing

    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

    Recall: Z-0109-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0109-2022
    Event ID
    88635
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 20, 2021
    Initiation Date
    September 10, 2021
    Classification Date
    October 13, 2021
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400

    Reason

    Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

    Code Info

    Software 2.51 and Lower

    Distribution

    US Nationwide

    Quantity

    2,169 units