| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00941-1 |
| Product Name/Description |
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air), software version 3.6.0
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
There are artifacts appearing on the tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds. In those cases only, the scan might be triggered either too soon or too late, which may lead to inappropriate contrast opacification during the clinical scan. If the acquired images are not diagnostically acceptable, a rescan of the patient need to be performed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Clinical judgment should be used by the customer/user to determine if the images acquired in the dataset contain enough information to make a diagnosis. Philips Healthcare is implementing software update version 3.6.2 to correct the issues. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |