BEUDAMED
    FDA Recall Terminated

    Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.

    Recall: Z-2210-2013 · Initiated July 5, 2013

    Recall

    Recall Number
    Z-2210-2013
    Event Number
    65691
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 5, 2013
    Posted
    September 16, 2013
    Terminated
    September 15, 2015
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.

    Reason

    The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.

    Action

    Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Care Center at 1-800-722-9377, option 5 for information concerning this issue.

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam.

    Quantity

    M/N: 728256, 4 units; M/N: 728246, 89 units; M/N: 728235, 9 units & M/N: 728231, 207 units