FDASeptember 30, 2025device

IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Ongoing

Brands named

impris imagingimpris

UPCs

00857534006189008575340061650085753400620200857534006196

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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