BEUDAMED
    56 results · 32ms · Sources: EU EUDAMED, US FDA

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    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

    FDA Recall
    Terminated ·Canon Inc. 30-2, Shimomaruko 3-chome, Ohta-ku Tokyo Japan·Product code MQB·November 1, 2010

    Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.

    FDA Recall
    Terminated ·Canon Inc. 30-2, Shimomaruko 3-chome, Ohta-ku Tokyo Japan·Product code HKO·December 5, 2012

    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

    Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015

    TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code IYE·September 18, 2008

    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·February 19, 2014

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015

    Rational Imaging TM Software, model Ultra 10 PACS System Version 7.1.Xx

    FDA Recall
    Terminated ·Canon USA Inc·Product code LMB·March 11, 2003

    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