BEUDAMED
    FDA Recall Terminated

    HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.

    Recall: Z-1185-2012 · Initiated February 6, 2012

    Recall

    Recall Number
    Z-1185-2012
    Event Number
    61238
    Firm
    Hamilton Medical Inc
    FEI Number
    2937708
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 6, 2012
    Posted
    March 7, 2012
    Terminated
    October 23, 2013
    Address
    4990 Energy Way P O Box 30008, Reno, NV, 89502-3008

    Description

    HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502. Product Usage: Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals.

    Reason

    Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions.

    Action

    Hamilton Medical sent a Medical Device Safety Alert and Correction Action letter dated February 17, 2011 to all affected customers via a traceable method. The letter identified the affected product, problem and immediate actions required by operators, distributor and manufacturer. The letter states that a Hamilton Medical Account manager will contact customers to schedule a convenient time for the Technical Support Department to install the software update. Questions or concerns may be directed to Technical Support Manager at 800-426-6331, Ext 125.

    Distribution

    (USA) Nationwide Distribution including the states of: CA, CO, FL, GA, MA, MI, MO, NC, NV, NY, PA, TN, TX, VA and WV.

    Quantity

    456 devices in US.