| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00680-1 |
| Product Name/Description |
Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare became aware of certain issues with the affected products through testing & customer feedback. The identified issues include;
- IMR Cardiac - Irregular Appearance of Contrast in Vessels;
- Missing Image Annotations in CCT
- Halo Artefacts
- Incorrect Z Annotation on Plan Box for Coronal/Sagittal Surviews
- Post Injection Delay Between Timed Scans may be Inaccurate
- Unintended Change of Acquisition Timing on Scan Ruler
- Bolus Tracker does not Trigger as Expected
- Cardiac Step & Shoot stops after Arrhythmia detected
- Tracker Scan Halted with FDOM
- Error when Auto ROI Placement Outside Patient Anatomy
- No "GO" when HR outside acceptable range
- Unplanned Results During Multi-Phase Pulmo Series, may Cause a System Crash
- Dynamic Myocardial Perfusion Acquisition Halted After 1st Shot
- Double Clicking ECG Phase Bar Crashes Exam Application
- Incorrect Phase Tolerance for Cardiac S&S &
- Ring Artefacts on High Resolution Images, iDose4 & IMR |
| 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 |