Agency classClass IIOur severity:High FDA (Devices)·Z-2044-2021·Announced 2021-07-21

Toshiba Vantage MRI System Recalled for Flame Retardancy Defect

Canon Medical's Toshiba Vantage Tiitan 1.5T MRI systems are being recalled due to a component that does not meet flame retardancy standards. The defect could result in smoke or fire. Affected units were 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: This medical device recall addresses a structural component that fails to meet flame retardancy standards, creating a potential fire and smoke hazard. No injuries or incidents have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High (3).

Plain-English summary

Canon Medical System, USA, Inc. is recalling select Toshiba Vantage Tiitan 1.5T MRI systems due to a component that does not meet the appropriate flame retardancy rating.

The affected component could result in smoke or fire. This presents a potential hazard to patients and medical facility personnel in proximity to the equipment.

The recalled MRI systems have been distributed nationwide across all United States regions. The recall identifies specific serial numbers of the affected units.

The recalled product

Product: Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - 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…
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: U4A12Z2020
S4D1132069
S4A1032017
U4B1492081
U4B1582100
S4A1072035
A4A1222019
S4D1172090
U4A1312024
S4A1072034
S4A1082040
A4A11Z2011
U4A1282003
U4B1442070
U4A1352035
U4B1552097
U4A12X2010
S4C1112065
S4C1112064
S3A0922024

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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