| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00146-1 |
| Product Name/Description |
myMerlin Application software versions v.1.0.6000, v.1.0.6001, or v.1.0.6002
Model APP1000 (Android), APP1001 (iOS)
ARTG's 401859, 401858 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The following problems may occur when the myMerlin Mobile Application (Model APP1000 and APP1001) is upgraded to software version v.1.0.6000, v.1.0.6001, or v.1.0.6002:
1. The next scheduled follow-up or scheduled device check transmission may not execute if it was pending at the time of the app upgrade to v.1.0.600X. The app will perform the pending workflow after the upgrade, however, will not schedule the next instance of the workflow until after the app has been closed and reopened.
2: A white screen may be displayed at initial launch of the app following upgrade to v.1.0.600X.
This action was undertaken prior to TGA notification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
All affected customers received the software update, version 2.0 for both Android and iOS, to prevent the problems from occurring. This software was released in released in April 2023.
This action has been closed out on 29/05/2024 |
| Contact Information |
02 8879 2877 - John Kilbridge |