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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00586-1
Product Name/Description Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 12/05/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue The following issues have been identified which may result in additional patient scanning & therefore additional radiation doses. There have been no reports of injuries as a result of these issues;
- Scan length changes with a change in the field of view (FOV);
- The DoseRight algorithm calculates a water equivalent diameter that is larger than measured on a cylindrical phantom when an 80 kVp or 120 kVp surview is used. This will result in a mAs value for the scan that is higher than suggested when using a 100 kVp or 140 kVp surview. (Note: The reported mAs and CTDI values are correct for all scans & surviews);
- Wrong scan time estimation due to incorrect intergration time causes the SurView scan near 184mm &135mm may result in unexpected scan start positions; &
- There may be a discrepancy between the calculated reconstruction length & the actual scan length which may result in the inability to reconstruct the raw data. Offline reconstruction of the raw data is also not possible.
Recall Action Recall for Product Correction
Recall Action Instructions Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction.

This action has been closed out on the 12/10/2018.
Contact Information 1800 251 400 - Philips Customer Care Centre