The Recall Desk
HighFDA (Devices)·Z-2045-2021·Announced 2021-07-21

Canon 1.5T MRI System Recalled for Flame Retardancy Component Failure

Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.

What this means for you

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 potential fire and smoke hazard from a component failing to meet flame retardancy requirements. Per the rubric, risk-of-harm products without reported injuries are scored High (3), as the hazard is real but no illnesses or deaths have been reported.

Plain-English summary

Canon Medical System, USA, INC. is recalling Canon Vantage Tiitan 1.5T MRI Systems (Model REF: MRT-1510) due to a component that does not meet appropriate flame retardancy standards. This component could result in smoke or fire.

The affected MRI systems are identified by specific serial numbers listed in the recall notice. The systems were distributed nationwide across all U.S. states and territories.

Facilities operating affected systems should contact Canon Medical System, USA, INC. for guidance on remediation or replacement of the non-compliant component.

The recalled product

Product
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - 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 sy
Manufacturer
Canon Medical System, USA, INC.
Category
Medical Device — Diagnostic Imaging / MRI System
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 (20)

  • Affected Serial Numbers: S3C18Y2032
  • S3C1892029
  • S3C1912035
  • S3C2042045
  • S3A16Z2007
  • S3B1782012
  • S3A1692003
  • S3C1912036
  • S3C2012043
  • S3C1882028
  • S3C19Z2042
  • S3B17Y2016
  • S3C1842019
  • S3C1912034
  • S3C18Z2033
  • S3C2012044
  • S3C2082046
  • S3B1762010
  • S3B1762009
  • S3C1872025

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 →

Related recalls

Same manufacturer · Canon Medical System, USA, INC.

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Same hazard · fire

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