Agency classClass IIOur severity:High FDA (Devices)·Z-2046-2021·Announced 2021-07-21

Canon MRI System Recalled for Flame-Retardancy Component Defect

Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.

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: Class II medical device with potential fire and smoke hazard from non-flame-retardant component. No illnesses, injuries, or deaths reported. Qualifies as 'risk-of-harm products where injury has not yet been reported' per the severity rubric.

Plain-English summary

Canon Medical System, USA, INC. is recalling Canon Vantage Titan 3T Premium Open-Bore MRI Systems (REF: MRT-3010) that were distributed nationwide. The systems contain a component that does not meet the appropriate flame-retardancy rating required for medical device safety.

The non-compliant component could result in smoke or fire during equipment operation. These systems are used in hospitals and medical facilities for diagnostic imaging to produce cross-sectional images of anatomical structures.

Owners and operators who received these systems should verify their serial numbers against FDA recall notice Z-2046-2021 and contact Canon Medical System for corrective action. Systems with affected serial numbers should not be used until the flame-retardancy issue is resolved.

The recalled product

Product: Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - 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
Hazard: fire
smoke
component-defect

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: A5B1182002
A5B11Y2005
A5D14X2032
A5A1082001
A5C12Y2017
A5D13Y2025
A5C1412028
S7A1642006
A5D13Y2026
A5F1562034
A5B1192004
A5C1222010
A5C1212009
A5C12X2016
A5G1692038
A5G1642036
A5C1232011
A5C1252012
A5D13Z2027
A5D1492030

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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