Recall
FDAHealthSeptember 30, 2025

IMPRIS Imaging Inc — IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida

⚠️ 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.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
September 30, 2025

Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.

What's affected?

Product
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Lot code
IMRIS Part Number(s): 120823-000, UDI/DI 00857534006806

Additional details

IMRIS Part Number(s): 120823-000, UDI/DI 00857534006806

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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