BEUDAMED
    43 results · 29ms · Sources: EU EUDAMED, US FDA

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    System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·May 3, 2022

    Canon Aquilion Prime, Model TSX-303A

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019

    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·December 8, 2020

    System INFX-8000C

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·February 5, 2021

    Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code KPS·September 17, 2024

    Canon Aquilion One, Model TSX-301A

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019

    The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·November 15, 2023

    Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·March 3, 2020

    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 body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·May 21, 2021

    Alphenix INFX-8000F, interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·December 19, 2025

    This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·September 2, 2025

    Canon Aquilion Premium, Model TSX-301B

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code JAK·March 25, 2019

    System INFX-8000V

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·February 5, 2021

    INFX-8000V. For radiographic and fluoroscopic studies and intervention.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·January 31, 2022

    The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·November 15, 2023

    MRI system: Vantage Elan, Model: MRT-2020

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·January 29, 2024

    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·January 29, 2024

    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 system is capable of non-contrast enhanced imaging, such as MRA.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·May 21, 2021

    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·December 8, 2020

    VANTAGE TITAN 3T Model MRT-3010/MEXL-3010

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·December 19, 2025