| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01163-1 |
| Product Name/Description |
Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT systems with software versions 4.1.2, 4.1.3 and 4.1.4
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
On the affected CT systems and software versions, the perfusion scan feature may be unavailable. No harm has been reported, and no potential harm because of unavailability of the scanner feature. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software update will be released to correct the issue by Philips. A Philips Field Service Engineer will contact customers to schedule the software update installation at their site. This action has been closed-out on 04/07/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |