BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance CT 16 Air. 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-1653-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1653-2015
    Event ID
    71177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2015
    Initiation Date
    March 16, 2015
    Classification Date
    May 22, 2015
    Termination Date
    February 22, 2017
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance CT 16 Air. 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 informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

    Code Info

    System Code #, 728246, Serial #, 3376, 3393, 3444, 3466, 3650, 4055, 5234, 5239, 5311, 5366, 5387, 5388, 5403, 5408, 5417, 5418, 5420, 5421, 5422, 5427, 5450, 5483, 5484, 5497, 5503, 5507, 5574, 5610, 5614, 5626, 5639, 5692, 5729, 5736, 5800, 5804, 5853, 5905, 5909, 5925, 5927, 5989, 5993, 6128, 6149, 6232, 6308, 6313, 6322, 6351, 6384, 6389, 6462, 6488, 6604, 30061, 50002, 50033, 50048, 50062, 50065, 50069, 50080, 50095, 50097, 50099, 50137 & 500006.

    Distribution

    Distributed in China.

    Quantity

    153 units total