| TGA Action ID |
RC-2025-RN-00858-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Siemens 3T MRI magnet systems (Verio) in IMRIS Operating Suites (iMRIX)
Product code: 105828-000 |
| ARTG Number |
168785 |
| Unique Device Identifier (UDI) |
00857534006165 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential safety problem associated with the magnet venting paths of Siemens 3T MRI system within the IMRIS Suite.
Siemens notified IMRIS that 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.
This poses a potential risk of asphyxiation to any person present in the scanning room. Furthermore, the sudden release of helium gas may cause cold burns and/or damage to persons or equipment. |
| Instructions for Customers/Users |
Siemens service organisation plans to inspect certain systems based on their data collection and if necessary, perform a correction.
Systems may continue to be used until the inspection has been performed.
UPDATE Nov 2025: Emergo has provided additional instructions to users in the event the associated error message occurs. This includes:
· Not reboot the system.
· Remove the patient from the system.
· Lock/secure all access to the scanning room with the system remaining energized at field.
· Post a “DO NOT USE” notice on or near the device.
· Call the local Siemens Healthineers service organisation as requested in the error message.
This action has been closed out on 13/02/2026 |
| Action Commencement Date |
7/10/2025 |
| Responsible Entity |
|
| Contact Information |
02 9006 1662 - Emergo Australia |