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Health Canada Medical devices

Philips Brilliance CT Big Bore System

Issued November 1, 2023
Issue
Philips has become aware of a potential safety issue with the Philips Big Bore RT and upgrade Brilliance CT Big Bore where it may be difficult for the user to accurately identify the image position under specific clinical scenarios. After performing an off-center reconstruction and sending the image data to other Therapy Planning Solution (TPS) workstations or exporting to a post processing software, a two-dimensional image shift (x and y coordinates) may occur. In oncology scenarios this could cause the contours to be misplaced or the iso center of the tumor to be incorrect. In radiology scenarios this could cause the relate function to show different positions on the intellispace portal or other post-processing workstations, when comparing images. Recall start date: October 13, 2023
Hazard description
Performance
Product
Product name
Philips Brilliance CT Big Bore System
Reference
ID
RA-74510