IMPRIS Imaging Inc recalls IMRIS Operating Suite

Recalling company

IMPRIS Imaging Inc

Product

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

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Sep 30, 2025

Reported

Nov 5, 2025

Distribution

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

Status

Ongoing

Quantity

N/A

Lot / codes

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

Company location

Chaska, MN

Recall type

Voluntary: Firm initiated

Recall number

Z-0162-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0162-2026 in the FDA Enforcement Report. Also see FDA recall press releases.