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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00766-1
Product Name/Description Brilliance iCT and iCT SP up to and including Software Version 3.2.5

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 24/07/2013
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue When using 80kVp with intravenous contrast in head and neck studies with U-filters (UA, UB, UC), a vascular artefact that resembles thrombus may appear on the image. There is a risk of misdiagnosis which can lead to unnecessary treatment of a patient. For certain patient populations, this could contribute to serious injury.
Recall Action Recall for Product Correction
Recall Action Instructions When the settings (80 kVp with intravenous contrast in head and neck studies with U-filters (UA, UA and UC)) are used, Philips recommends performing additional reconstruction with a non-U filter and comparing the result images to verify no such artefact is evident. Customers are advised to continue to use 80 kVp with U-filters for brain perfusion scans. Refer to the Instructions for Use (IFU) for the selection of an arterial input unaffected by discontinuity should one occur.
Contact Information 1800 251 400 - Philips Customer Care Centre