| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00096-1 |
| Product Name/Description |
Merlin.net Web Application and Database
Model: APP1000 (Android), APP1001 (iOS)
ARTG's 401858, 401859 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The Confirm Rx symptom EGM report sent by a patient-initiated transmission using the myMerlin Mobile Application (Model APP1000 and APP1001) will not be displayed on Merlin.net if a specific sequence of events occurs.
The symptom EGM data is not lost as it is included and processed with the transmission and can be provided upon clinician request.
This action was undertaken prior to TGA notification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
All affected devices have received the software update, Merlin.net MN5000 v7.8. rev4, which corrects the problem. This software update was released on November 21, 2023.
This action has been closed out on 29/05/2024 |
| Contact Information |
02 8879 2877 - John Kilbridge, Abbott Medical Australia |