BEUDAMED
    FDA Enforcement Class II Terminated

    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation 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-0871-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0871-2022
    Event ID
    89702
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    February 14, 2022
    Classification Date
    April 4, 2022
    Termination Date
    January 7, 2025
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation 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

    Cybersecurity Improvement Action-not equipped against potential cyber security threats

    Code Info

    All Lots/Serial Numbers. UDI: 04048675250418

    Distribution

    US Nationwide

    Quantity

    13,687 (2,987 units US)