BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system 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-2116-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2116-2016
    Event ID
    74427
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 6, 2016
    Initiation Date
    April 1, 2016
    Classification Date
    June 30, 2016
    Termination Date
    June 26, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

    Reason

    Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.

    Code Info

    Brilliance 64: System Code #728231 Serial numbers: 9847, 9936, 9937, 9963, 10067, 10146, 10155, 10181, 10184, 10189, 10191, 10216, 10240, 10292, 10768, 10769, 10770, 10771, 10772, 10773, 10774, 10776, 10777, 10778, 10779, 10780, 10781, 10782, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10790, 10791, 10794, 10804, 10807, 29026, 29048, 29065, 29081, 29118, 29151, 91003, 95116, 95142, 95523, 95571, 95660, 95838, 95839, 95840, 95841, 95842, 95843, 95845, 95846, 95847, 95848, 95849, 95850, 95851, 95852, 95853, 95854, 95855, 95856, 95857, 95858, 95863, 95866, 95870, 95871, 95872, 95873, 95877, 95882, 95884, 95885, 95886, 95888, 95889, 95890, 95891, 95892, 95893, 95895, 95896, 95897, 95939, 6000861, 9208A, 9081

    Distribution

    US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX

    Quantity

    94