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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01235-1
Product Name/Description Brilliance iCT/iCP SP, CT 64, Ingenuity CT/Core/Core 128 with software version 4.1.6

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/09/2017
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips have identified that upon completion of the scan procedure during Bolus tracking on a Brilliance iCT with software version 4.1.6, no images were generated. This leads to unavailability of raw data for offline reconstruction.

This issue always leads to CT rescan.
Recall Action Recall for Product Correction
Recall Action Instructions Philips Healthcare is advising users that a Field Service engineer will perform an update to the system to correct the issue.

This action has been closed out on the 11/12/2018.
Contact Information 1800 251 400 - Philips Customer Care Centre