| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01333-1 |
| Product Name/Description |
Brilliance iCT with Software Version 4.1.0.19260
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
Philips has detected a situation where ring artifacts may occur. The conditions that may create these specific ring artifacts occur when a user:
1. Selects a non-gated helical scan with automatic scan time on
2. They edit the Preview images using ‘Edit before final Recon’ (Reconstruction); and,
3. The automatic scan time algorithm is executed after the scan has been acquired.
Presence of ring artifacts affecting diagnostic quality of images may result in a rescan. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To avoid the occurrence of these specific ring artifacts users can implement the following work around:
1. Disable Automatic Scan Time for all Exam Cards
2. Leave Automatic Scan Time on during planning and prior to clicking 'Go' to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan.
3. Disable Edit Before Final Reconstruction for all Exam Cards.
If ring artifact is present clinical judgement should be used to determine if rescan is required. A software update will be implemented to correct the problem. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |