BEUDAMED
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    MultiDiagnost MD4

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·June 12, 2007

    OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·March 1, 2007

    GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of exams for various clinical applications with ether 23 cm image intensifier with 512x512 Image Chain or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image Chain.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAA·December 18, 2007

    Axiom Iconos R200 X-Ray

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAA·January 29, 2010

    Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device brochure is labeled in part: "Philips...Mobile C-Arm system BV Endura".

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·September 5, 2008

    Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device's brochure is labeled in part: "Philips...Mobile C-Arm systems BV Pulsera".

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·September 5, 2008

    Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code JAA·October 4, 2011

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·February 22, 2008

    OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code JAA·November 19, 2007

    Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trained doctors or technologists on both adult and pediatric subjects taking radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in prone or supine positions.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAA·September 12, 2017

    CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code JAA·October 19, 2017

    OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code JAA·May 1, 2018

    Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.

    FDA Recall
    Terminated ·Philips North America, LLC·Product code JAA·February 28, 2019

    GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities and other body parts.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAA·December 10, 2020

    Hospitak, REF 962-E, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·August 23, 2007

    Philips Medical System - BV Pulsera Mobile C-arms with Remote Control Option, (Release 2)

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·August 23, 2007

    GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 89 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32 cm or 40 cm image intensifier.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAA·December 18, 2007

    OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·April 15, 2008