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Recall Observatory FDA recall evidence

Device product

Brilliance CT Big Bore Oncology, Model number 728243 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.

Z-2653-2016

July 20, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 74820
Status
Terminated
Classification
Class II
Quantity
33
Official record key
device-enforcement:Z-2653-2016

Official wording

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 information: 728243  Brilliance BigBore Oncology CT 7116 7611 7354 7063 7309 7169 7205 7016 7019 7043 7069 7073 7091 7112 7132 7163 7141 7194 7226 7325 7294 7350 7316 7480 7114 7210 7310 7438 7530 7186 7119 7042

Distribution pattern: 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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can