| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00755-1 |
| Product Name/Description |
Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions:
(Computed tomography (CT) full-body diagnostic X-ray system)
4.0.x.xxxx – Any version of 4.0
4.1.y.xxxx – Only version up to and including 4.1.4.
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Some scans unexpectedly set the Axial (Z axis) scan length to a greater length than the user set in the plan.
The issue occurs only when the following 3 conditions are met:
· The plan employs Dual-SurView
· The plan requests either a Sagittal or a Coronal reconstruction.
· The gantry is tilted
Due to this issue, there is a potential for undesired radiation to areas not intended to be scanned. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is developing a new version of software that will eliminate the defect. Deployment of this new software will begin before the end of April, 2016. All customers will be updated by the end of October, 2016. In the interim, to eliminate the possibility of the defect from occurring, the user can eliminate any one of the three conditions (identified above) needed to trigger the behaviour. If the user chooses to eliminate the reconstruction from the plan, then that reconstruction can be created after the scan is complete. This action has been closed out on 15 June 2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |