| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00147-1 |
| Product Name/Description |
myMerlin Mobile Application (iOS) version 1.0.1003
Model number: APP1001
ARTG 401859
(Abbott Medical Australia Pty Ltd - myMerlin Mobile Application Model APP1001 (iOS) - Implantable cardiac monitor patient programmer) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
In a specific set of circumstances using the MyMerlinApp App1001 version 1.0.1003, when the user taps the "Send Data Now" button to upload data to Merlin.net, the "Send Data Now" button may be displayed again instead of the expected Success screen. The above sequence repeats, with no apparent upload success.
This action was undertaken prior to TGA notification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
All customers received the updated software, MyMerlinApp App1001 version 1.0.6001, which corrected the problem. This update was available in April 2023.
Please note: This problem does not exist in later versions of myMerlin iOS APP1001.
This action has been closed out on 29/05/2024 |
| Contact Information |
02 8879 2877 - John Kilbridge |