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    Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is PC based devise that allows for worklist management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit, is configurable with up to two x-ray tubes, and has an auto switching function. This system is intended for use in conjunction with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck and limbs. The system is used for image acquisition, image display and transmission/output or images to external devices.

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code MQB·October 16, 2018

    Canon Aquilion Prime, Model TSX-303A

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

    Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position patient during diagnostic and interventional x-ray angiography.

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code MQB·February 8, 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

    Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

    FDA Recall
    Terminated ·Canon Medical System, USA, INC.·Product code KPS·November 11, 2020

    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

    CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - 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
    Terminated ·Canon Medical System, USA, INC.·Product code OWB·October 8, 2020

    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