Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0Used with associated Pinnacle3 Tumor LOC server (version 14.0) 의 리콜

Recall

RC-2018-RN-00085-1

Class I

2018-01-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00085-1

Philips became aware of issues with brilliance big bore ct systems running software version 4.2.0. the most significant issues are:1- efov (extended field of view) check message does not display when fov is set >600mm for a paused scan2- prefer “center x/y 0” and “disable result rotation” checkboxes checked automatically when checking the "ct simulation"3- tumor loc allows poi (point of interest) locking when a non-isocenter slice is displayed4- tracker scan completed, no images were generated5- continuous link plans the clinical scan outside the surview6- applying tilt on first mpr result, when the other axial results are unplanned causes change in scan length and number of cycles of scan7- “system is still initializing. please wait…” error8- auto locations not functioning as expected9- system ended exam before completion10- system freeze-up after pause is pressed.

Philips is releasing a Field Change Order (FCO) to correct these issues. A Philips Field Service Engineer will contact users to schedule the FCO updates. In the interim, users are advised to refer to the Customer Letter for respective actions in regards to the outlined issues.