BEUDAMED
    FDA Recall Terminated

    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177

    Recall: Z-1628-2021 · Initiated April 6, 2021

    Recall

    Recall Number
    Z-1628-2021
    Event Number
    87753
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    MNT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 6, 2021
    Terminated
    January 17, 2024
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177

    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.

    Action

    In April, 2021, Philips issued an Urgent Medical Device Removal notice to customers via letter notifying them that Philips determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. ACTION TO BE TAKEN BY CUSTOMER / USER 1. Locate all impacted devices listed above immediately STOP USE. All impacted devices must be removed from service. Replace with a non-impacted device if it is being used by a patient. 2. This notice needs to be passed on to all those who must be aware within your organization or to any organization where the impacted devices have been transferred. 3. Once impacted devices have been removed from service and isolated notify your Philips Representative that the impacted devices are ready for return. Your Philips Representative will arrange for return of the device. Replacements will be provided free of charge. 4. Fill out the Business Reply Form that has been provided with this letter and return it to your Philips Representative. This form serves as official acknowledgement that you have fully performed your obligations to complete this medical device recall.

    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

    4 units