| TGA Action ID |
RC-2025-RN-00735-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
3 Tesla MRI Systems
Multiple product names and material numbers |
| ARTG Number |
154128, 274035, 387372 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Siemens has identified a potential safety problem associated with the magnet venting paths of 3 Tesla MRI systems.
An ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
In the event of a magnet quench combined with a complete ice blockage of the designed vent paths, vaporised helium gas could leak into the scanning room.
This poses a potential risk of asphyxiation to any person present in the scanning room. The sudden release of helium gas may cause cold burns and/or damage to persons or equipment.
To date no global incident or problems have occurred causing harm. |
| Instructions for Customers/Users |
Seimens will contact customers to organise an inspection of the device and implement the correction if necessary.
This problem can only be identified by qualified personnel from a Siemens service organisation. To help mitigate any potential risks follow the instructions outlined in the customer letter.
This action has been closed out on 30/03/2026 |
| Action Commencement Date |
25/08/2025 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |