BEUDAMED
    FDA Recall 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 · Initiated December 19, 2012

    Recall

    Recall Number
    Z-0741-2013
    Event Number
    64117
    Firm
    Hamilton Medical Inc
    FEI Number
    2937708
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 19, 2012
    Posted
    January 31, 2013
    Terminated
    April 22, 2014
    Address
    4990 Energy Way P O Box 30008, Reno, NV, 89502-4123

    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.

    Action

    Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Questions should be addressed to Hamilton Medical at 800-426-6331 ext 215

    Distribution

    US Nationwide Distribution including the country of Switzerland.

    Quantity

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