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Recall Observatory FDA recall evidence

Device product

Brilliance BigBore Radiology CT Model number 728244 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-2654-2016

July 20, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 74820
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-2654-2016

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: 728244  Brilliance BigBore Radiology CT 7375 7781 7614 7633 7708 7789 7721 7760 7252 7380 7390 7514 7052 7244 7384 7533 7172 7200 7546 7427 7452 7407 7453 7586

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