# FDA recall Z-0163-2026

> **IMPRIS Imaging Inc** · Class I · device recall initiated 2025-09-30.

## Product

IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA

## 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

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

## Key facts

- **Recall number:** Z-0163-2026
- **Recalling firm:** IMPRIS Imaging Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-30
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0163-2026

## Citation

> AI Analytics. FDA recall Z-0163-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0163-2026. Source: US FDA. Licensed CC0.

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