75 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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 Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA.
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DQK·February 16, 2007
GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA.
FDA Recall
Terminated
·General Electric Medical Systems Information Technology·Product code DQK·February 16, 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 Inspection Technologies x|tome|x L240 an Cabinet X-ray system
FDA Recall
Terminated
·Product code RCE·January 13, 2015
GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
FDA Recall
Terminated
·Product code RCE·January 13, 2015
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
FDA Enforcement
Class II
·Terminated·GE Healthcare·October 14, 2015
NM 830 Model # H3910AC
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 870 DR Model # H3100AS
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery 670 DR Model # H3100BT
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 860, SPECT/CT
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery NM 630 Model # H3101RH
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 870 CZT Model # H3906CW
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
NM/CT 850 Model Number: H3907AD
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
Discovery NM670 Pro Model # H3100XB
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·August 14, 2020
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2,GE Healthcare, Waukesha, WI. 53188
FDA Recall
Terminated
·GE Healthcare·Product code LLZ·September 10, 2007
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
FDA Recall
Terminated
·Product code RCE·December 16, 2015
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
FDA Recall
Terminated
·Product code RCE·June 28, 2017
IgE Calibrator Series
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code DGC·September 7, 2016
ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code DGC·March 5, 2018