BEUDAMED
    FDA Recall Terminated

    Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

    Recall: Z-0495-2013 · Initiated November 9, 2012

    Recall

    Recall Number
    Z-0495-2013
    Event Number
    63709
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 9, 2012
    Posted
    December 10, 2012
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

    Reason

    Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

    Action

    Philips sent an URGENT - Medical Device Correction letter dated November 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Philips is conducting a voluntary correction to replace the audio cable on affected devices. Customer were instructed to follow the "Action to be taken by CustomerUser" section of the instructions. Customers with wquestions were instructed to contact their Phililps representataive or contact the Customer Care Solutions Center at (800) 722-9377. For questions regarding this recall call 978-687-1501.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    3165