The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2047-2021·Announced 2021-07-21

Canon Vantage Galan 3T MRI System Recalled for Fire Risk

Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.

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: FDA Class II recall for a fire/smoke hazard in a medical imaging device with no reported injuries or illnesses. Per the severity rubric, this represents a risk-of-harm scenario where the potential for injury exists but has not yet been reported, warranting a High (3) classification.

Plain-English summary

Canon Medical System, USA, INC. is recalling certain Canon Vantage Galan 3T MRI systems (model MRT-3020) due to a component that does not meet the appropriate flame retardancy rating. This defect could result in smoke or fire.

The affected MRI systems were distributed nationwide across all U.S. states and Puerto Rico. The recall includes 18 specific units identified by serial number.

Patients and healthcare facilities using affected systems should contact Canon Medical System immediately for further guidance. No injuries or illnesses have been reported at this time.

The recalled product

Product
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 display anatomic structures of the head or body. Additionally, this system is capable of non-contrast…
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — Diagnostic Imaging / MRI
Hazard

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 (18)

  • Affected Serial Numbers: D5A2082005
  • S7B1992017
  • S5C1912050
  • S5A1662001
  • D5A2092007
  • S5B17X2034
  • S5B18X2046
  • S5A17X2033
  • S5A1742021
  • D5A2062003
  • S5C18Y2048
  • S5A1732019
  • S5A1732018
  • S5A17Y2035
  • S7B1892004
  • S5B1842043
  • S7B1962013
  • S5C1972054

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Canon Medical System, USA, INC. 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 4 products in this recall →

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