BEUDAMED
    FDA Recall Terminated

    Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip 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 is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

    Recall: Z-2217-2011 · Initiated May 3, 2011

    Recall

    Recall Number
    Z-2217-2011
    Event Number
    58667
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 3, 2011
    Posted
    May 19, 2011
    Terminated
    April 25, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip 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 is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

    Reason

    PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation

    Action

    Philips Healthcare issued an Urgent - Medical Device Correction letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the "Action to be taken by Customer/User" section of the instructions while they await the correction, which will likely come in the form of a replacement audio cable for all affected speaker assemblies. For further information or support concerning this issue, please contact Philips Healthcare Customer Care Service Center at 800-722-9377 # 3, # 1 and reference the letter or your local Philips representative in your area.

    Distribution

    Worldwide Distribution - USA (nationwide) and the country of Canada

    Quantity

    15062 units