BEUDAMED
    FDA Enforcement Class III Completed

    HAMILTON-H900 Humidifier, Models: 950001, 950004

    Recall: Z-1385-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1385-2022
    Event ID
    90460
    Classification
    Class III
    Status
    Completed
    Product Type
    Devices
    Firm
    Hamilton Medical AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2022
    Initiation Date
    January 5, 2021
    Classification Date
    July 14, 2022
    Address
    Via Crusch 8, Bonaduz, N/A, Switzerland

    Description

    HAMILTON-H900 Humidifier, Models: 950001, 950004

    Reason

    When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

    Code Info

    UDI:07630002801546. All devices with software version 1.10c

    Distribution

    US: WI, FL, CA, NV, PA, TX, PA

    Quantity

    203