| TGA Action ID |
RC-2025-RN-00353-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
CardiacSense Wristwatch - Telemetry System Transmitter Electrocardiograph |
| ARTG Number |
387674 |
| Unique Device Identifier (UDI) |
387674 |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
CardiacSense Wristwatch provided by Talius Group, were found to be non-compliant with the Essential Principles of safety and performance as determined during a TGA post-market review.
The use of devices may pose a risk of inaccurate data, and this could lead to delayed or incorrect diagnosis, improper treatment and potential harm to the wearer’s health.
This action was undertaken prior to notification to the TGA recalls section. |
| Instructions for Customers/Users |
Customers are to contact sales@talius.com.au to arrange a replacement watch or a refund for an affected watch. |
| Action Commencement Date |
3/04/2025 |
| Responsible Entity |
|
| Contact Information |
0438 391 914 - Graham Russell |