The Recall Desk
HighFDA (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.

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: 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 bo
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: 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 →

Related recalls

Same manufacturer · Canon Medical System, USA, INC.

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Same hazard · fire

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