| TGA Action ID |
RC-2025-RN-00784-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
ScottCare ARRIO Holter device
MCT Holter Event Recorder
Product code: 102113
Identifiers: AR00001 - AR00300 |
| ARTG Number |
354095 |
| Unique Device Identifier (UDI) |
102113 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
When the ARRIO device is configured to be used in offline mode, there is potential for early depletion of the device battery, particularly when the Wi-Fi access points are enabled. The ARRIO device will be frequently seeking to connect to unavailable Wi-Fi access points, which significantly reduces the battery life to 2-4 hours.
This can result in missed patient events, and incomplete recordings. This may require patient return and repeating the tests. |
| Instructions for Customers/Users |
Customers are to:
1. Replace the existing Instructions for Use with the updated version.
2. Disable the Wi-Fi access points when using the device in Offline mode.
3. Ensure battery is fully charged prior to patient use.
4. Replace any battery over 12 months old or showing signs of shortened storage.
This action has been closed out on 08/01/2026 |
| Action Commencement Date |
15/09/2025 |
| Responsible Entity |
|
| Contact Information |
03 9882 0000 - Dancor Pty Ltd T/a Boab Medical Technologies |