BEUDAMED
    FDA Recall Terminated

    Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray 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. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    Recall: Z-0945-2013 · Initiated December 20, 2012

    Recall

    Recall Number
    Z-0945-2013
    Event Number
    64401
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 20, 2012
    Posted
    March 13, 2013
    Terminated
    April 17, 2014
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray 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. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    Reason

    Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.

    Action

    Philips Healthcare sent a "Urgent Medical Device Correction" letter dated December 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed Philips received reports from the field stating that the screws holding the vertical brake together failed. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information please contact your local Philips representative or local Philips Healthcare office. For North America and Canada Contact the Customer Care Solutions Center at ( 1-800-722-9377, option 5: Enter Site ID or follow the prompts.

    Distribution

    Worldwide Distribution - Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.

    Quantity

    4797 Units