BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.

    Recall: Z-2709-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2709-2014
    Event ID
    69123
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    December 27, 2005
    Classification Date
    September 25, 2014
    Termination Date
    November 6, 2015
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.

    Reason

    The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

    Code Info

    728256, 728251, 728246, 728240, and 728235.

    Distribution

    Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.

    Quantity

    364