BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance CT 16 Power, Model number 728240 Product Usage: 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-2656-2016 · Reported August 31, 2016

    Enforcement

    Recall Number
    Z-2656-2016
    Event ID
    74820
    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
    August 31, 2016
    Initiation Date
    July 20, 2016
    Classification Date
    August 25, 2016
    Termination Date
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance CT 16 Power, Model number 728240 Product Usage: 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

    After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.

    Code Info

    728240 -- Brilliance CT 16 Power 3100 5043 5047 5280 5345 5390 5413 5430 5495 5499 5512 6007 6009 6013 6032 6041 6045 6049 6051 6058 6064 6066 6070 6071 6077 6080 6081 6084 6089 6095 6100 6106 6109 6113 6115 6116 6123 6124 6131 6132 6134 6141 6144 6155 6161 6162 5476 6098 6120 6067

    Distribution

    US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY

    Quantity

    50