Vantage Galan 3T MRT-3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987670102615), received between Oct 16, 2024 and Mar 24, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K162183, K173382, K181593, K183657, K192506, K192574, K203323, K203553, K211037, K212056, K220192, K222387, K230355, K241496, K243335); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 19, 2025Class IIOpen, Classified

   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.

   Z-1017-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 10, 2024Class IIOpen, Classified

   The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

   Z-2041-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT, WHO HAD PREVIOUSLY BEEN SCANNED ON THE SYSTEM WITH NO ISSUES, HAD OPEN HEART SURGERY AND HAD A PLATE PUT IN THEIR CHEST, COMPLAINED OF A HEAT FEELING ON THEIR CHEST DURING A POST-SURGERY SCAN. TECHS STOPPED SCANNING AND BROUGHT PATIENT TO 1.5T TITAN ON SITE AND COMPLETED THE SCAN WITHOUT FURTHER INCIDENT. POST SCAN TECH GAVE PATIENT AN ICE PACK AND PATIENT LEFT AND LATER CALLED SITE TO REPORT REDNESS IN AREA OF CHEST PLATE WHERE HEAT/BURN WAS FELT AND REPORTED THEY WILL REPORT THE INCIDENT TO THE PLATE MANUFACTURER.

  Patient problems: Skin Burning Sensation

  MAUDE report 24675884 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A SKIN BURN ON THEIR UPPER THIGH DURING A T-SPINE EXAM. THERE WAS NO COIL CONTACT BUT THE PATIENT'S THIGH MAY HAVE BEEN TOUCHING THE INNER BORE. THE SCAN PARAMETER FOR THIS EXAM INDICATED THAT THE PATIENT WAS RATED AS 375LBS AND JUST FIT THE BORE.

  Patient problems: Burn(s)

  MAUDE report 21996809 ↗
• InjuryOct 16, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON SEPTEMBER 4, 2024, CANON WAS MADE AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2024. A PATIENT WHO HAD UNDERGONE AN MRI EXAMINATION COMPLAINED TO THE HOSPITAL OF HEARING DISCOMFORT. AS A RESULT OF OUR INVESTIGATION, THREE CASES (<1> TO <3>) WERE FOUND TO HAVE OCCURRED, AND SUBSEQUENTLY CASE <4> WAS REPORTED. (B)(6) (1ST CASE) FEMALE PATIENT, PELVIC EXAMINATION: THE PATIENT COMPLAINED OF HEARING DISCOMFORT DURING THE MRI EXAMINATION. AS THE DISCOMFORT CONTINUED THE NEXT DAY, THE PATIENT VISITED AN OTOLARYNGOLOGIST. THE PATIENT CONTINUED TO VISIT THE OTOLARYNGOLOGIST THEREAFTER. (B)(6) (2ND CASE) FEMALE PATIENT, PELVIC EXAMINATION: THE PATIENT COMPLAINED OF HEARING DISCOMFORT DURING THE MRI EXAMINATION. AS THE DISCOMFORT CONTINUED THE NEXT DAY, THE PATIENT MADE A SINGLE VISIT TO AN OTOLARYNGOLOGIST. (B)(6) (3RD CASE) FEMALE PATIENT, PELVIC EXAMINATION: CANON RECEIVED A REPORT FROM THE HOSPITAL THAT THEIR PATIENT HAD COMPLAINED OF EAR PROBLEMS. NO REPORTS OF VISITING A HOSPITAL. (B)(6) (4TH CASE) MALE PATIENT, ABDOMINAL EXAMINATION: IN THE MORNING, IMAGING FOR THE ABDOMEN WAS PERFORMED USING A CANON MRI SYSTEM. AN HOUR LATER, THE PATIENT UNDERWENT A HEAD EXAMINATION USING THE MRI OF A

  Patient problems: Hearing Impairment

  MAUDE report 20465852 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162183, K173382, K181593, K183657, K192506, K192574, K203323, K203553, K211037, K212056, K220192, K222387, K230355, K241496, K243335. One submission often covers many models, so check the product and lot details in each record.

• Z-0327-2026 · Oct 16, 2025 · Open, Classified
  VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.
• Z-2047-2021 · May 21, 2021 · Open, Classified
  Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that dis