427 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code LNH·October 6, 2009
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
FDA Recall
Terminated
·Cairn Diagnostics·Product code PGE·January 8, 2021
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - 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 JAA·August 30, 2013
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
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·January 21, 2015
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·January 21, 2015
GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.
FDA Recall
Terminated
·GE Healthcare·Product code JAA·January 2, 2008
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