| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01223-1 |
| Product Name/Description |
Ingenuity CT system with software version 4.1.5
Model Number: 728326
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
On the affected CT system and software version, the perfusion scan feature may be unavailable. No harm has been reported and there is no potential harm because of the 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 |