FDA-Device2025-11-05Class IPROCESSING DEFECT
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Affected count
N/A
Manufactured in
1230 Chaska Creek Way Ste 100, N/A, Chaska, MN, United States
Products
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2026Want us to check the next one for you?
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