BEUDAMED
    FDA Recall Terminated

    The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.

    Recall: Z-0121-2008 · Initiated September 27, 2007

    Recall

    Recall Number
    Z-0121-2008
    Event Number
    44950
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 27, 2007
    Posted
    November 7, 2007
    Terminated
    March 2, 2012
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.

    Reason

    The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.

    Action

    Notification letters were sent to the installed customer base informing them of the hazard on 10/1/2007. A mandatory corrective software release due out mid October 2007, will be available at no cost to the customer. The software will be installed by Philips Field Service Engineers.

    Distribution

    Worldwide, including USA, Canada, France, Finland, Korea, Australia, Italy, Switzerland, China, Austria, Thailand, Malaysia, Denmark, Norway, Jordan, Netherlands, England, South Africa, Spain, Germany, Bahrain, Belgium, New Zealand, Puerto Rico, South Korea, Saudi Arabia, Czech Republic, Sweden, Israel, and Lithuania

    Quantity

    206 systems