| 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 |
|
| 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 |