| TGA Action ID |
RC-2025-RN-00481-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Salix (AU)
Software Version: v1.8.0. |
| ARTG Number |
347719 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A change was implemented in Salix (AU) v1.8.0 to allow the user to select a different series from the one automatically chosen by the system. If the user selects a ‘contrast’ series for analysis, the system will automatically bring in the ‘non-contrast’ series for analysis as well, which will overwrite any user-edited information in the previous non-contrast series, including the calcium score.
As a result, the user might not be aware that the data has been overwritten, leading to a different calcium score in the final report.
This defect does not affect any other previously released versions of Salix (AU). To date, no adverse events have been reported. |
| Instructions for Customers/Users |
A hotfix will be applied to software version v1.8.1. When the user selects a new contrast series for analysis, a warning will be displayed to notify users that the calcium score edits will be reset.
Until this hotfix is applied, whilst using Salix (AU) v1.8.0, customers are to be aware that selecting an alternate contrast series for analysis will result in overwriting any user-edited information in the non-contrast series, including the calcium score.
This action has been closed out on 19/08/2025 |
| Action Commencement Date |
21/05/2025 |
| Responsible Entity |
|
| Contact Information |
0405 653 605 - Gabriela Quijada |