Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1017-2026 — VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

U.S. FDA — Device Enforcement · United States · 2025-12-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1017-2026
Date of alert
2025-12-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Canon Medical System, USA, INC.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04987670102615
Reported risk: There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.