| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00197-1 |
| Product Name/Description |
Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)
ARTG: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
1- Swirl-like ring artifacts may appear on reconstructed images impairing the diagnostic quality.
2- When executing two bolus scans the system may freeze during the second tracker execution, impacting countdown timer displayed to the user which indicates the start of the clinical scan.
3- There are inconsistencies between the GUI and the Instructions for Use (IFU)/Technical Reference Guide (TRG): English version 459800340361_A documentation for the (QA) testing
4- Teflon and other pins HU values are incorrectly documented in the IFU/TRG |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is provided information and work around instructions to mitigate some of the issues. A software update and revision of the Instructions for Use (IFU) documentation will be implemented to correct the issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |