PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: November 5, 2025 Initiated: September 30, 2025 #Z-0161-2026

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
IMPRIS Imaging Inc
Units Affected
N/A
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Sweden, Switzerland, Japan, Australia, Qatar, and China.
Location
Chaska, MN

Frequently Asked Questions

What product was recalled?
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio. Recalled by IMPRIS Imaging Inc. Units affected: N/A.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 5, 2025. Severity: Critical. Recall number: Z-0161-2026.