BEUDAMED
    FDA Recall Terminated

    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    Recall: Z-1065-2016 · Initiated January 18, 2016

    Recall

    Recall Number
    Z-1065-2016
    Event Number
    73177
    Firm
    Philips Respironics
    FEI Number
    3007871739
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 18, 2016
    Posted
    March 7, 2016
    Terminated
    May 26, 2017
    Address
    1740 Golden Mile Hwy, Monroeville, PA, 15146-2012

    Description

    Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    Reason

    Software Issue

    Action

    Philips Respironics has determined that affected devices may continue to be used in accordance with the device Instructions for Use and the Field Safety Notification that is being issued to customers. Philips Respironics will be providing a software update for affected devices free of charge. Customers will be notified by mail when the software update is available for download. For further questions please call ( 724 ) 387-7500.

    Distribution

    Nationwide Distribution including Puerto Rico and Internationally to the US Virgin Islands.

    Quantity

    104,508 units