BEUDAMED
    676 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    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 Q ceiling, Model Number 10848281

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 23, 2022

    Artis zee biplane MN, Model Number 10094143

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·February 23, 2022

    Azurion IGTS Fixed Systems

    FDA Recall
    Open, Classified ·Philips North America·Product code OWB·October 4, 2023

    Allura Xper IGTS Fixed Systems

    FDA Recall
    Open, Classified ·Philips North America·Product code OWB·October 4, 2023

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024

    Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·July 15, 2024

    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