| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01196-2 |
| Product Name/Description |
Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
While performing High Resolution head scans, the reconstructed images may exhibit degraded image quality manifested as:
- Non uniformity of the image,
- CT number shift, greater than 5 Hounsfield units,
- Reduction in grey/white matter differentiation.
The issue is most severe in the high resolution mode. Philips provides factory reference paediatric scan protocols which are set to high resolution by default. Adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to perform head scan with standard resolution across all patient populations on systems running the affected software. Philips will be implementing a software correction as a permanent correction.
This action has been closed-out on 15/03/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |