BEUDAMED
    FDA Enforcement Class II Ongoing

    HAMILTON-C6, REF: 160021

    Recall: Z-1429-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1429-2023
    Event ID
    91925
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hamilton Medical AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2023
    Initiation Date
    March 14, 2023
    Classification Date
    April 25, 2023
    Address
    Via Crusch 8, N/A, Bonaduz, N/A, N/A, Switzerland

    Description

    HAMILTON-C6, REF: 160021

    Reason

    Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

    Code Info

    Software Version: 1.2.1, UDI-DI: 07630002808590

    Distribution

    US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.

    Quantity

    103