The Recall Desk

FDA (Devices) recall action 88014

Canon Medical System, USA, INC. recalled 4 products on 2021-07-21

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-07-21
Critical
0
Units
—

Why these products were recalled

The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··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.

    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 syste
    Category
    Distribution
    46 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    46 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2021-07-21

    Canon Vantage Galan 3T MRI System Recalled for Fire Risk

    Canon Medical System is recalling Canon Vantage Galan 3T MRI systems due to a component that does not meet flame retardancy standards, which could result in smoke or fire. The recall affects units distributed nationwide.

    Product
    Canon Vantage Galan 3T, REF: MRT-3020 - 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 system is capable of non-contrast e
    Category
    Distribution
    46 states