BEUDAMED
    FDA Enforcement Class I Terminated

    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics

    Recall: Z-0741-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0741-2013
    Event ID
    64117
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hamilton Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2013
    Initiation Date
    December 19, 2012
    Classification Date
    January 31, 2013
    Termination Date
    April 22, 2014
    Address
    4990 Energy Way, P O Box 30008, Reno, NV, 89502-4123, United States

    Description

    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics

    Reason

    Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.

    Code Info

    Software Versions 1.1.2 and below; Part numbers 161005, 161006.

    Distribution

    US Nationwide Distribution including the country of Switzerland.

    Quantity

    97 total ventilators; 69 of part number 161005 and 28 of part number 161006