193 results
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Sources: EU EUDAMED, US FDA
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MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·February 13, 2014
Axiom Aristos TX. Model number 58 94 873 Radiology system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·June 10, 2005
Product's marketing brochure is labeled in part: "Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code KPR·January 21, 2009
Philips Easy Diagnost Eleva
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code KPR·July 23, 2007
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.
FDA Recall
Terminated
·GE Healthcare·Product code KPR·March 7, 2008
Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·February 17, 2011
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstandbucky to complete x-ray exposures.
FDA Recall
Terminated
·Carestream Health Inc.·Product code KPR·August 20, 2013
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code KPR·July 22, 2015
DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
FDA Recall
Terminated
·Agfa-Gevaert, N.V. Prins Boudewijnlaan Kontich Belgium·Product code KPR·December 4, 2018
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·January 8, 2020
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·January 8, 2020
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Recall
Terminated
·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code KPR·March 26, 2018
Essenta DR is a digital multifunctional X-ray systems, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile X-ray table (trolley). The intended use is from direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code KPR·August 15, 2008
Philips Bucky DIagnost X-Ray System
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code KPR·July 23, 2007
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code KPR·July 11, 2012
Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034 Product Usage: Radiological image processing system (computed radiography x-ray system)
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code KPR·February 14, 2012
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·September 3, 2013
Philips DuraDiagnost stationary X-ray system
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code KPR·September 17, 2015
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics
FDA Recall
Terminated
·Visaris DOO Batajnicki Drum 10 Deo 1B Belgrade·Product code KPR·April 5, 2018
Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·August 6, 2018