BEUDAMED
    FDA Recall Terminated

    Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810

    Recall: Z-0451-2008 · Initiated November 13, 2007

    Recall

    Recall Number
    Z-0451-2008
    Event Number
    45843
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    November 13, 2007
    Posted
    December 11, 2007
    Terminated
    August 15, 2016
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810

    Reason

    Alarm failure : If changes are made to the Caregroup Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group

    Action

    Philips Medical notified customers by letter dated November 2007 titled : Urgent Medical Device Correction Notice. Customers will be instructed to follow the Procedure to Mitigate Risk section * of the notice while they await the correction of their devices with a mandatory software upgrade to be performed by service representatives. * (no changes are to be made to the Caregroup Editor configuration on any system. If changes have already been made to the configuration prior to receipt of this notification, turn each bedside monitor "off " and then "on" in order to reset the system-Customer Care Contact telephone 1-800-722-9377)

    Distribution

    Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.

    Quantity

    60 units