Official recall record
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-12-19
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04987670102615
- Brand on record
- Canon Medical System, USA, INC.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography c
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