DeviceClearance

Recall Z-0161-2026— IMPRIS Imaging Inc

Class I · Ongoing

Class I FDA medical device recall by IMPRIS Imaging Inc, initiated 2025-09-30. It names 4 FDA 510(k) clearances: K212367, K133692, K101813 and 1 more. Product: IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio. Reason: 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..

Recalling firm
IMPRIS Imaging Inc
Classification
Class I
Status
Ongoing
Initiated
2025-09-30
Firm location
Chaska, MN, United States

510(k) clearances named in this recall

4 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.