BEUDAMED
    FDA Enforcement Class II Ongoing

    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

    Recall: Z-3262-2024 · Reported October 2, 2024

    Enforcement

    Recall Number
    Z-3262-2024
    Event ID
    95173
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fisher & Paykel Healthcare, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2024
    Initiation Date
    August 7, 2024
    Classification Date
    September 25, 2024
    Address
    15 Maurice Paykel Place, East Tamaki, Auckland, N/A, New Zealand

    Description

    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.

    Reason

    Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.

    Code Info

    Model Number: PT301US UDI-DI code: 09420012466662 Lot/Serial Numbers:

    Distribution

    U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided

    Quantity

    944 units