IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida
Published November 5, 2025 · Recall initiated: September 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- IMPRIS Imaging Inc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
- Lot
- IMRIS Part Number(s): 120823-000, UDI/DI 00857534006806
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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