# FDA recall Z-0327-2026

> **Canon Medical System, USA, INC.** · Class II · device recall initiated 2025-10-16.

## Product

VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

## Reason for recall

Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

## Distribution

US distribution to Ohio and Nevada

## Key facts

- **Recall number:** Z-0327-2026
- **Recalling firm:** Canon Medical System, USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-16
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tustin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0327-2026

## Citation

> AI Analytics. FDA recall Z-0327-2026. Retrieved 2026-08-21 from https://api.ai-analytics.org/recall/Z-0327-2026. Source: US FDA. Licensed CC0.

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