Home / Recalls / IMPRIS Imaging Inc / Z-0162-2026

Z-0162-2026 Class I Ongoing

Recalled by IMPRIS Imaging Inc — Chaska, MN

Recall Details

Product Type: Devices
Report Date: November 5, 2025
Initiation Date: September 30, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Product Description

IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra

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.

Distribution Pattern

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

Code Information

IMRIS Part Number(s): 116053-000, UDI/DI 00857534006035; 116117-000, UDI/DI 00857534006042; 116118-000, UDI/DI 00857534006059; 116119-000, UDI/DI 00857534006066.