BEUDAMED
    FDA Recall Terminated

    Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    Recall: Z-0950-2013 · Initiated February 15, 2013

    Recall

    Recall Number
    Z-0950-2013
    Event Number
    64436
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 15, 2013
    Posted
    March 14, 2013
    Terminated
    April 11, 2014
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    Reason

    This field change order is being released to update software and customer release notes to the affected installed base.

    Action

    Philips Healthcare sent an Urgent Medical Device Correction letter dated February 13, 2013, via certified mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter. Customers were instructed to retain a copy with the equipment Instruction for Use. For questions customers were instructed to contact their local Phillips representative or local Philips Healthcare office. For North Americal and Canada contact Customer Care Solutions Center at 1-800-722-9377, option 5: Enter Site ID or follow the prompts For questions regarding this recall call 1-800-722-9377.

    Distribution

    Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland.

    Quantity

    42 Units