BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.

    Recall: Z-2382-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2382-2016
    Event ID
    74131
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    April 29, 2016
    Classification Date
    August 10, 2016
    Termination Date
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.

    Reason

    Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.

    Code Info

    Brilliance iCT SP Model No. 728311 S/N:200107,200003,200011,200009,200017,200074,200022,200013,200027,200049,200032, 200030,200043,200040,200038,200047,200051,200044,200063,200061,200068,200067, 200089,200088,200092,200093,200101,200097,200100,200105,200109,200121,200204, 200111,200117,200127,200131,200200,200205,200138,200202,200201,200203,200209, 200210,200206,200208,200207,200211,200019,200015,200029,200024,200023,200025, 200026,200041,200086,200102,200213

    Distribution

    Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, 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, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

    Quantity

    57 Units