BEUDAMED
    FDA Enforcement Class I Completed

    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

    Recall: Z-0915-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0915-2020
    Event ID
    84551
    Classification
    Class I
    Status
    Completed
    Product Type
    Devices
    Firm
    ResMed Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    December 12, 2019
    Classification Date
    February 6, 2020
    Address
    1 Elizabeth Macarthur Dr, N/A, Bella Vista, N/A, N/A, Australia

    Description

    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

    Reason

    Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.

    Code Info

    Serial Number Range: 20160123307 to 22171057208

    Distribution

    U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT

    Quantity

    69