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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00197-1
Product Name/Description Brilliance 64, software version and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)

ARTG: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/03/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue 1- Swirl-like ring artifacts may appear on reconstructed images impairing the diagnostic quality.

2- When executing two bolus scans the system may freeze during the second tracker execution, impacting countdown timer displayed to the user which indicates the start of the clinical scan.

3- There are inconsistencies between the GUI and the Instructions for Use (IFU)/Technical Reference Guide (TRG): English version 459800340361_A documentation for the (QA) testing

4- Teflon and other pins HU values are incorrectly documented in the IFU/TRG
Recall Action Recall for Product Correction
Recall Action Instructions Philips is provided information and work around instructions to mitigate some of the issues. A software update and revision of the Instructions for Use (IFU) documentation will be implemented to correct the issue.
Contact Information 1800 251 400 - Philips Customer Care Centre