BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT SP 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

    Recall: Z-1353-2016 · Reported April 20, 2016

    Enforcement

    Recall Number
    Z-1353-2016
    Event ID
    73338
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2016
    Initiation Date
    February 5, 2016
    Classification Date
    April 8, 2016
    Termination Date
    July 2, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance iCT SP 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

    Reason

    The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

    Code Info

    Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051, 200061, 200063, 200067, 200068, 200074, 200088, 200093, 200097, 200100, 200101, 200105, 200107, 200109, 200111, 200117, 200121, 200127, 200131, 200138, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200209, 200210 & 200211.

    Distribution

    Worldwide Distribution - US to the District of Columbia: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WV. Product was also shipped to the following countries: Afghanistan, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Cuba, Denmark, Egypt, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Lebanon, Lithuania, Macedonia, Malawi, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestinian, Philippines, Poland, Republic of Korea, R¿union, Romania, Russian Federation, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

    Quantity

    49 Units