Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

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.

On 12/19/2025, the firm sent via Adobe DocuSign an "Urgent: Medical Device Correction" letter to customers informing them that It has been discovered that in the superconducting magnet used in the applicable system, if there is slow leakage, over a long period of time, of refrigerant gas from the superconducting magnet, air ingress into the helium vessel via the leak point may result in ice forming. If this is left unchecked, the worst-case scenario is that the helium gas will not be able to escape through the designed exhaust path, and the helium tank could eventually rupture, releasing helium gas into the MR scan room. For safety management of the superconducting magnet, the status of the magnet is checked during maintenance inspections and continuously monitored by a remote monitoring system. However, in response to the above report from the manufacturer of the superconducting magnet, an inspection to check for slow gas leaks in the superconducting magnet used in systems installed at our customer sites will be provided as a repair service. Note that there have been no reports of health hazards related to this incident. Customer are instructed to: The system can continue to be used. However, please ensure there are adequate evacuation routes from the scan/imaging room and the control room. Additionally, do not press the quench button in cases other than emergencies. A representative of Canon Medical Systems USA will contact you to schedule an inspection. If you have any questions regarding this matter, please contact your service representative. Share the contents of letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at their facility. In addition, posted the Recall Letter on or near potentially affected systems. For any questions regarding this letter please contact Orlando Tadeo, Director Regulatory Affairs, at 800-421-1968 or otadeo@us.medical.canon or your Canon service representative at 800-521-1968.

• FDA enforcement recordOfficial FDA database entry for Z-1017-2026
• FDA 510(k) clearance · K230355The device's official FDA premarket clearance record
• FDA device classification · LNHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1000The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Canon Medical System, USA, INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.