Health product recall

Philips Brilliance CT Big Bore System

Last updated

Summary

Product
Philips Brilliance CT Big Bore System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Philips CT Big Bore

All lots.

728242

Brilliance CT Big Bore System-Main Unit

All lots.

728244

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

Philips Medical Systems Nederland B.V.

Veenpluis 6, Best, Netherlands, 5684 PC

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74510

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