28 results
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108ms
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Sources: EU EUDAMED, US FDA
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Enforcement
Class II
·Terminated·General Electric Med Systems LLC·June 20, 2012
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
FDA Enforcement
Class II
·Terminated·General Electric Med Systems LLC·June 20, 2012
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Enforcement
Class II
·Terminated·General Electric Med Systems LLC·June 20, 2012
Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IXR·October 21, 2004
GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·May 31, 2006
Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. The system combines the high performance Lightspeed Plus CT with high performance PET that is optimized for routine 2D and 3D oncology, cardiology and neurology clinical studies.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code KPS·January 26, 2006
Sopha Medical Vision DST / DST-XL Digital vatiable angle Nuclear Imaging System
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code KPS·September 27, 2005
Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code LLZ·October 8, 2004
LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IYN·September 2, 2004
GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·March 26, 2007
Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IZH·November 16, 2005
Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator''s console.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code KPR·December 30, 2004
GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System).
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·February 5, 2007
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·May 31, 2006
GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code KPR·May 31, 2006
GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular Imaging System).
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·February 5, 2007
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.).
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·February 5, 2007
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular).
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·March 26, 2007
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·March 26, 2007
GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic applications.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code KPR·May 31, 2006