| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00681-1 |
| Product Name/Description |
Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software version 4.1.3, 4.1.4 and 4.1.5
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare became aware of certain issues with the affected products through testing and customer feedback. The identified issues include;
- IMR Cardiac - Irregular Appearance of Contrast in Vessels;
-Missing Image Annotation’s in CCT;
- Halo Artefacts;
- Unable to Match Z Locations on Prescan and 4D CT Scan;
- Incorrect Z Annotation on Plan Box for Coronal/Sagittal Surviews;
- Unintended Change of Acquisition Timing on Scan Ruler;
- Bolus Tracker does not Trigger as Expected;
- System Unresponsive when Paused;
- System Becomes Unresponsive During Timed Scan;
- Unplanned Results During Multi-Phase Pulmo Series, may Cause a System Crash;
- Communication Errors Between Host Computer & Gantry; and
- Pin Wheel Artefact Using 0.67mm Slice Width. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |