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Sources: EU EUDAMED, US FDA
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GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects 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 OWB·December 12, 2013
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 Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·April 13, 2015
GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
FDA Recall
Terminated
·GE Healthcare·Product code OWB·May 29, 2015
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code OWB·November 3, 2015
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. " Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). " Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code OWB·November 3, 2015
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code OWB·November 3, 2015
GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
FDA Recall
Terminated
·Regulatory Insight, Inc·Product code OWB·July 1, 2008
Cios Alpha, mobile X-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·February 19, 2016
CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·February 16, 2016
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·February 18, 2016
Artis Q and Q.Zen fluoroscopic x-ray system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·February 27, 2017
Artis zee biplane, Model Number 10094141
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Artis zee floor MN, Model Number 10094142
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Artis zee ceiling, Model Number 10094137
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
FDA Recall
Terminated
·Philips North America, LLC·Product code OWB·April 3, 2020
Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·July 30, 2020
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·March 19, 2021
Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·May 1, 2018
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 22, 2018
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code OWB·April 19, 2021