BEUDAMED
    FDA Recall Terminated

    Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169

    Recall: Z-1182-2007 · Initiated July 16, 2007

    Recall

    Recall Number
    Z-1182-2007
    Event Number
    38400
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 16, 2007
    Posted
    September 5, 2007
    Terminated
    August 1, 2016
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169

    Reason

    Incorrect Patient Assignment: the information center will in most cases be associated with the "incorrect" patient. This occurs on both standalone and networked systems running fixed mode monitoring. (This does not occur on systems that run flex mode monitoring)

    Action

    Philips Medical Systems issued a letter notification dated July 2007 " Urgent Device Correction". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made.

    Distribution

    Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK

    Quantity

    76 units