| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00085-1 |
| Product Name/Description |
Brilliance Big Bore Oncology CT, Brilliance Big Bore Radiology CT with software version 4.2.0
Used with associated Pinnacle3 Tumor LOC server (version 14.0)
ARTG Number: 98868 (Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips became aware of issues with Brilliance Big Bore CT systems running software version 4.2.0. The most significant issues are:
1- EFOV (extended field of view) check message does not display when FOV is set >600mm for a paused scan
2- Prefer “center x/y 0” and “disable result rotation” checkboxes checked automatically when checking the "CT Simulation"
3- Tumor LOC allows POI (Point of Interest) locking when a non-isocenter slice is displayed
4- Tracker scan completed, no images were generated
5- Continuous Link plans the clinical scan outside the Surview
6- Applying tilt on first mpr result, when the other axial results are unplanned causes change in scan length and number of cycles of scan
7- “System is still initialising. Please wait…” error
8- Auto locations not functioning as expected
9- System ended exam before completion
10- System Freeze-Up After Pause is Pressed |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is releasing a Field Change Order (FCO) to correct these issues. A Philips Field Service Engineer will contact users to schedule the FCO updates. In the interim, users are advised to refer to the Customer Letter for respective actions in regards to the outlined issues.
This action has been closed out on 15/02/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care |