FDA Device recall Z-0163-2026
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
- FDA Device
- Class I
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class I recall of IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA by Impris Imaging, citing there is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0163-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-09-30 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Impris Imaging |
| Distribution | US |
Product
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Reason
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating 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 which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Identifiers
| code_info | IMRIS Part Number(s): 120823-000, UDI/DI 00857534006745 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0163-2026%22
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