136 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and are also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The systems may be used for other imaging applications at the physician's discretion.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·November 6, 2009
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·October 10, 2008
UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·March 27, 2007
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·November 19, 2007
GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·August 16, 2006
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·November 19, 2007
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·November 20, 2006
InstaTrak 3500 Navigation and Visualization System
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code LLZ·July 12, 2004
GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·August 16, 2006
GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·September 28, 2007
OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·March 1, 2007
OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·March 1, 2007
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·November 20, 2006
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·October 3, 2014
OEC MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OXO·October 3, 2014
Uroview 2000 X-ray System
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·May 12, 2003
Uroview 2500 X-ray System
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·May 12, 2003
OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code JAA·January 15, 2007
OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code OWB·October 3, 2014
ENTrak Navigation and Visualization System
FDA Recall
Terminated
·GE OEC Medical Systems, Inc·Product code LLZ·July 12, 2004