IMPRIS Imaging Inc recalls IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

Recall date

September 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0163-2026

FDA classification

Class I

Brand / firm

IMPRIS Imaging Inc

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA