BEUDAMED
    FDA Recall Terminated

    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Recall: Z-1745-2014 · Initiated December 19, 2013

    Recall

    Recall Number
    Z-1745-2014
    Event Number
    67879
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 19, 2013
    Posted
    June 22, 2014
    Terminated
    August 25, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    Reason

    During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically, at the 48MHZ frequency, the testing indicated the Brilliance CT Big Bore was 3.5dB uV/meter higher than the applicable IEC 60601-1-2 standard specification.

    Action

    Philips Medical System sent an Urgent Medical Device Corrections letters dated December 10, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a field service Engineer will visit the facility to perform an Electro-Magnetic Interference (EMI) noise reduction up0date on each system. For information or support concerning contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, OptionS: Enter site ID or follow prompts).

    Distribution

    Worldwide Distribution - US (nationwide) in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. and countries of Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, France, French Polynesia, Gabon, Germany, India, Indonesia, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Oman, Palestine, Philippines, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Ukraine & United Kingdom.

    Quantity

    454 Units