BEUDAMED
    FDA Enforcement Class II Terminated

    BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

    Recall: Z-1626-2021 · Reported June 2, 2021

    Enforcement

    Recall Number
    Z-1626-2021
    Event ID
    87753
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 2, 2021
    Initiation Date
    April 6, 2021
    Classification Date
    May 21, 2021
    Termination Date
    January 17, 2024
    Address
    1001 Murry Ridge Ln, N/A, Murrysville, PA, 15668-8517, United States

    Description

    BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

    Reason

    Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.

    Code Info

    Serial Number: V30446637ACAE, V30446653BE5A, V304441360854, V304457587F98, V304468408502, V304441766F34, V3044555732D7, V30446846E034, V30444034719A, V3044642346EA.

    Distribution

    Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan

    Quantity

    10 units