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Sources: EU EUDAMED, US FDA
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AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 24, 2014
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·August 12, 2014
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 8, 2014
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 17, 2014
Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/dig. imager)
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·February 16, 2012
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·September 2, 2014
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2020
Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for digital radiography.
FDA Recall
Terminated
·Philips Healthcare Inc.·Product code KPR·April 1, 2011
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·March 6, 2013
(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 Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 4, 2013
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 7, 2013
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·July 7, 2014
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·May 7, 2013
Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray imager (flat panel/digital imager)
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·February 15, 2012
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 26, 2020
SIEMENS Healthineers Luminos dRF Max Model: 10762471- 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 JAA·January 8, 2020
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 3, 2015
Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 26, 2020
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·May 6, 2013
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 11, 2014