BEUDAMED
    FDA Recall Terminated

    Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    Recall: Z-1896-2010 · Initiated June 10, 2010

    Recall

    Recall Number
    Z-1896-2010
    Event Number
    55939
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 10, 2010
    Posted
    June 24, 2010
    Terminated
    November 18, 2010
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    Reason

    It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.

    Action

    Philips Respironics has contacted all of its consignees by phone and instructed them to remove the potentially affected external battery packs from their inventory and any that may be on their patients/end users. These consignees have been instructed to quarantine batteries they have removed away from flammable materials. Product return/replacement instructions were provided. For further information, contact Philips Respironics at 1-877-387-3311.

    Distribution

    Worldwide Distribution -- United States (MT, IL, IA, NY, NC, TX, CA and FL), France, South Korea and Turkey.

    Quantity

    23 units