| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01235-1 |
| Product Name/Description |
Brilliance iCT/iCP SP, CT 64, Ingenuity CT/Core/Core 128 with software version 4.1.6
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips have identified that upon completion of the scan procedure during Bolus tracking on a Brilliance iCT with software version 4.1.6, no images were generated. This leads to unavailability of raw data for offline reconstruction.
This issue always leads to CT rescan. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is advising users that a Field Service engineer will perform an update to the system to correct the issue.
This action has been closed out on the 11/12/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |