BEUDAMED
    FDA Recall Terminated

    Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

    Recall: Z-2035-2012 · Initiated July 2, 2012

    Recall

    Recall Number
    Z-2035-2012
    Event Number
    62498
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 2, 2012
    Posted
    July 19, 2012
    Terminated
    December 24, 2013
    Address
    595 Miner Road, Cleveland, OH, 44143-2131

    Description

    Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

    Reason

    Philips Healthcare was notified that several of the sixteen bolts securing the brackets which support the carbon table top on various models of their Brilliant CT scanner have been found to be defective and the bolt heads may break off.

    Action

    Philips sent a Urgent Medical Device Correction letter dated June 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will visit each site to inspect and correct the issue, and Philips will be tracking the progressof the correction. For further information, Customers were asked to contact their local Philips representative or Philips Healthcare Office. North American and Canadian consignees should contact the Philips Customer Care Solutions Center at 1-800-722-9377

    Distribution

    Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, MJ, NM, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, VT, and WI. and the countries of Canada, Argentina, Australia, Austria, Azerbaijan, Brazil, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Iceland, India, Indonesia, Iraq, Italy, Jordan, Kazakhstan, Kazakhstan, Libyan Arab Jamahiriya, Malaysia, Mexico, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Palestine, Peru, Philipines, Poland, Portugal, Russia, Russia Fed, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Syrian Arab Republic, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Yemen.

    Quantity

    524