BEUDAMED
    FDA Recall Terminated

    Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.

    Recall: Z-1443-2008 · Initiated January 29, 2008

    Recall

    Recall Number
    Z-1443-2008
    Event Number
    46942
    Firm
    Philips Healthcare Informatics, Inc.
    FEI Number
    3002971142
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 29, 2008
    Posted
    August 16, 2008
    Terminated
    September 25, 2008
    Address
    4100 E 3rd Ave, Ste 101, Foster City, CA, 94404-4819

    Description

    Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.

    Reason

    When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool.

    Action

    The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem.

    Distribution

    Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.

    Quantity

    3 units