| TGA Action ID |
RC-2025-RN-00984-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
suiteHEART cMRI Analysis
Software version 5.1.2 |
| ARTG Number |
407410 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Inaccurate Global T1 along with wide fitting error values may be shown to the user if study data signal intensity differs between slices — meaning inter-slice shading is present — and the inversion time for the same frame number varies across slices.
When acquiring more than one slice for T1 mapping, the Global T1 value for native and post time series (original source images) may be inaccurate when inversion times vary across slices.
The Global T1 value is obtained by fitting a time curve. This curve is generated by averaging the signal intensities of all myocardial pixels across all slices. However, if signal intensity differs between slices — meaning inter-slice shading is present — and the inversion time for the same frame number varies across slices, the global time curve will fluctuate. These fluctuations lead to a larger fitting error. |
| Instructions for Customers/Users |
Customer is to be aware of the potential problem and workaround.
The problem has been resolved in the new release of the software (version: 5.1.3) and is now available to install. The manufacturer, NeoSoft, will contact the customer to schedule this update.
This action has been finalised on 8/5/2026. |
| Action Commencement Date |
20/11/2025 |
| Responsible Entity |
|
| Contact Information |
02 9006 1662 - Emergo Australia |