Agency classClass IIOur severity:High FDA (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.

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 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…
Manufacturer: Canon Medical System, USA, INC.
Category: Medical Device — Diagnostic Imaging / MRI System
Hazard: fire
smoke

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 →

Same manufacturer · Canon Medical System, USA, INC.

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