IMPRIS Imaging Inc: Medical Device Recall in 2025 - (Recall #: Z-0162-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 30, 2025

Date Posted: November 5, 2025

Recall Number: Z-0162-2026

Event ID: 97750

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.

Status: Ongoing

Product Quantity: N/A

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated