Vantage Titan 3t recallZ-1018-2026 · Canon Medical System, USA, INC. · initiated Dec 19, 2025

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] or your Canon service representative at 800-521-1968.

Recall details

Recall number

Z-1018-2026

Status

Open, Classified

Initiated by the company

Dec 19, 2025

Posted by the FDA

Jan 13, 2026

Recalling firm

Canon Medical System, USA, INC.

Quantity

22 systems

Product code

LNH

FDA submissions

K191128

Distribution

U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI.

Product description

VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Vantage Titan 3T MRT-3010

  Canon Inc. · System, nuclear magnetic resonance imaging
  2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 98112).

• Z-1017-2026 · Open, Classified
  VANTAGE GALAN 3T Model MRT-3020/MEXL-3020