BEUDAMED
    FDA Recall Terminated

    Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.

    Recall: Z-2346-2008 · Initiated July 3, 2008

    Recall

    Recall Number
    Z-2346-2008
    Event Number
    48986
    Firm
    Philips Healthcare Informatics, Inc.
    FEI Number
    3002971142
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 3, 2008
    Posted
    September 18, 2008
    Terminated
    October 7, 2009
    Address
    4100 E 3rd Ave, Ste 101, Foster City, CA, 94404-4819

    Description

    Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.

    Reason

    Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.

    Action

    A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.

    Distribution

    Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria

    Quantity

    198 systems