The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1071-2026·Announced 2026-01-21

MRI systems recalled over ice that may block the magnet venting system

Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states a blocked vent path could rupture the helium vessel and release gas into the scanning room, and no injuries are reported.

Plain-English summary

The Canon VANTAGE GALAN 3T, model MRT-3020/MEXL-3020, is being recalled by Canon Medical System, USA, Inc.

There is a potential for the formation of ice in the venting system of the superconducting magnet of the MRI systems. The firm states that 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.

The record lists 34 systems carrying UDI-DI 04987670102615, with model and serial numbers recorded in the enforcement record. Distribution was nationwide in the United States, in California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Missouri, Montana, Nevada, New York, Ohio, Oregon, Pennsylvania and Puerto Rico among other locations. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow Canon's instructions.

The recalled product

Product
Allura Xper FD20 Biplane; Model Number: 722013;
Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Medical Device — MRI system
Hazard
Affected units
23

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Number: 722013
  • System Product Name: Allura Xper FD20 Biplane
  • UDI-DI: 00884838059061
  • Serial Numbers: 601
  • 230
  • 370
  • 27
  • 320
  • 193
  • 60
  • 373
  • 560
  • 400
  • 549
  • 506
  • 381
  • 382
  • 132
  • 169
  • 233

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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