BEUDAMED
    FDA Enforcement Class I Ongoing

    Ventilator HAMILTON-C6, PN: 160021

    Recall: Z-2020-2024 · Reported June 26, 2024

    Enforcement

    Recall Number
    Z-2020-2024
    Event ID
    94671
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hamilton Medical AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2024
    Initiation Date
    May 15, 2024
    Classification Date
    June 18, 2024
    Address
    Via Crusch 8, N/A, Bonaduz, N/A, N/A, Switzerland

    Description

    Ventilator HAMILTON-C6, PN: 160021

    Reason

    Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.

    Code Info

    UDI: 07630002808590, Software Versions: SW v1.1.4, SW v1.1.5, SW v1.1.6

    Distribution

    US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA.

    Quantity

    68