BEUDAMED
    FDA Enforcement Class I Ongoing

    DreamStation Auto BiPAP. Non-Continuous Ventilator.

    Recall: Z-2228-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2228-2025
    Event ID
    97191
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips Respironics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 20, 2025
    Initiation Date
    June 30, 2025
    Classification Date
    August 8, 2025
    Address
    1001 Murry Ridge Ln, N/A, Murrysville, PA, 15668-8517, United States

    Description

    DreamStation Auto BiPAP. Non-Continuous Ventilator.

    Reason

    Devices may possess a programming error resulting in an incorrect device configuration.

    Code Info

    Model No. UDSX700S11F; UDI: 606959429772; Serial No. J18909076CC90, J2091514323C5, J2164570462CB, J23391208BCBE, J26552747A030, J2909781691D2, J294724447698, J301490021E77.

    Distribution

    Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE, NJ, NY, PA, TX & DC. The country of France.

    Quantity

    8 units