43 results
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24ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LLZ·July 15, 2022
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
EVair air compressor, model numbers: M1230849 and M1230847
FDA Recall
Open, Classified
·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
FDA Recall
Open, Classified
·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023
EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60 HZ, Model Number M1230849; e) NIST/CEE 7/7 230V 50/60 HZ, Model Number M1230849;
FDA Recall
Open, Classified
·Datex-Ohmeda, Inc.·Product code BTI·December 29, 2023
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
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
FDA Recall
Open, Classified
·DRE Medical Group Inc·Product code MNT·May 15, 2023