| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00051-1 |
| Product Name/Description |
Spectral CT 7500
Product Code: 728333
Software Version: 5.0
ARTG 321687
(Philips Electronics Australia Ltd - X-ray system, diagnostic, computed tomography, full-body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified that there is a software issue that can incorrectly label all captured images as the “Last Shot”.
Images incorrectly labelled as “Last Shot” may lead to misdiagnosis and subsequent incorrect treatment.
This issue is found in software version 5.0 for Spectral CT 7500 systems.
Philips has not received any reports of an adverse event associated with this issue as of December 2023 |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
1. To avoid the issue, the Operator can update the default exam card to have 1mm slice thickness and not thicker slices. In these cases, the issue will not be seen.
o As outlined in the Interventional (CCT) Workflow section in the Instructions for Use: Basic parameters can be changed without pausing the procedure. To change the slice thickness, select “Change Parameters” while the images are still displayed.
2. Customers may continue to use their system(s) in accordance with the intended use and by following the recommendation listed above.
3. Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and install the software update to resolve the issue (FCO72800808 for Spectral CT 7500).
The solution is in development and an estimated timeline for release is Q3 of 2024. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team. |