BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance CT 16 Power Computed Tomography X-ray systems is 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-2370-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2370-2016
    Event ID
    73750
    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
    March 24, 2016
    Classification Date
    August 9, 2016
    Termination Date
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

    Reason

    Software defect causing intermittently slow response of Host.

    Code Info

    Model #: 728240; Serial #s: 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6007, 6009, 6013, 6032, 6041, 6045, 6049, 6051, 6058, 6062, 6064, 6066, 6067, 6070, 6071, 6077, 6080, 6081, 6084, 6089, 6095, 6098, 6100, 6106, 6109, 6113, 6115, 6116, 6119, 6120, 6123, 6124, 6131, 6132, 6134, 6141, 6144, 6155, 6161, 6162.

    Distribution

    Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, 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 sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

    Quantity

    55 units