| TGA Action ID |
RC-2025-RN-00390-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Merlin 2 Patient Care System Programmer
Model Number: MER3700 |
| ARTG Number |
455027 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Abbott is updating Merlin 2 programmer MER3700 software to version 2.3.2 revision 1, which contains software enhancements and one software correction.
The software correction expands the Merlin 2 frequency range used for inductive communication. This addresses a problem that resulted in the inability of the Merlin 2 programmer to interrogate a small percentage of devices outside the Merlin 2 frequency range.
This matter is not likely to cause any serious adverse events.
There have been no reported patient clinical symptoms or harms. |
| Instructions for Customers/Users |
An Abbott Representative will contact customers to facilitate the upgrade of the Merlin 2 programmer to software version 2.3.2 revision 1 or above.
This action has been finalised on 5/5/2026. |
| Action Commencement Date |
29/04/2025 |
| Responsible Entity |
|
| Contact Information |
1800 839 259 - Abbott Medical Australia |