401 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System,
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007
OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code JAA·April 16, 2009
Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code JAA·October 4, 2011
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
FDA Recall
Terminated
·Hologic, Inc.·Product code JAA·September 14, 2012
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·April 10, 2008
GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.
FDA Recall
Terminated
·OEC Medical Systems, Inc·Product code JAA·August 29, 2008
Digital Radiography System Model DFP-8000D/FPD,
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005
GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·July 6, 2007
GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·June 12, 2007
EasyDiagnost Eleva x-ray systems
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code JAA·December 10, 2008
Electrophysiology Imaging System
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code JAA·April 28, 2005
Electrophysiology Imaging System
FDA Recall
Terminated
·Fischer Imaging Corporation·Product code JAA·April 28, 2005
OEC 9900 Elite (NAV) 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
OEC 9800 MD Motorized C-Arm System, 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 version e 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, and 50KW or 65 kW pulsing generator. The system is configured with a 23 cm image intensifier and a 512x512 Image Chain.
FDA Recall
Terminated
·GE Healthcare·Product code JAA·December 18, 2007
Toshiba Infinix-i, INFX-8000F The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·December 21, 2010
AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·January 16, 2012
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic 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 the prone or supine position.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAA·November 8, 2013
SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: Querying and retrieving patient history information and/or previous diagnosis and images from other modalities, including X-ray examinations of the urogenital area, Ultrasound examinations, Endourological interventions, Percutaneous interventions, Laparoscopy, Application of fistula, Simple procedures, Extracorporeal shock wave lithotripsy, Uroflow/urodynamics, Pediatric radiological and therapeutic applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·April 13, 2015