226 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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GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·May 31, 2006
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
FDA Recall
Terminated
·Eos Imaging Inc·Product code MQB·June 19, 2012
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
FDA Recall
Terminated
·Carestream Health Inc.·Product code MQB·August 29, 2013
Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures.
FDA Recall
Terminated
·Ge Healthcare, Llc·Product code MQB·June 3, 2010
Axiom Artis Systems operating with A100 Generator
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·March 4, 2010
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MQB·August 5, 2009
Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MQB·July 31, 2009
GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code MQB·August 17, 2006
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System
FDA Recall
Terminated
·Datex Ohmeda, Inc·Product code MQB·May 19, 2008
DRAD-3000E: Radrex-i X-ray is a general purpose X-ray System. Labeling reads in part "TOSHIBA***DIGITAL RADIOGRAPHY SYSTEM RADREX-i DRAD-3000E Systems Data No. MSDXR0144EA***"
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code MQB·December 29, 2011
Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code MQB·April 3, 2012
ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.
FDA Recall
Terminated
·Swissray Medical AG Turbistrasse 25-27 Hochdorf Switzerland·Product code MQB·November 14, 2018
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
System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. It is not designed for mammography use. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·April 6, 2020
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018
DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018
CombiDiagnost R90 (Stitching Patient Support) 709030
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code MQB·June 27, 2018
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