BEUDAMED
    FDA Recall Terminated

    Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.

    Recall: Z-2024-2012 · Initiated April 27, 2012

    Recall

    Recall Number
    Z-2024-2012
    Event Number
    62393
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 27, 2012
    Posted
    July 23, 2012
    Terminated
    November 1, 2012
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. They are not intended to be used as a transport ventilator.

    Reason

    The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.

    Action

    Respironics, Inc. began contacting its affected US customers by phone beginning on Friday, April 27, 2012, and requested that they quarantine any affected devices within their possession and that they retrieve any devices with patients and quarantine those as well. Replacement devices were to be provided to all affected customers. For questions customers should call 724-387-7651. For questions regarding this recall call 877-387-3311..

    Distribution

    Worldwide Distribution - USA including AZ, CA, IL, IN, LA, MI, MN, MO, NJ, NY, NC, PA, SC, TN, TX, and WI and the countries of Canada, Denmark, Estonia, Finland, France, Great Britian, India, Italy, Japan, Korea, Saudi Arabia, and Spain.

    Quantity

    173