24 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Completed
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Revolution CT
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·July 14, 2021
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Enforcement
Class II
·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020
VariCam
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
VariCam
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·October 30, 2017
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Recall
Completed
·GE Healthcare, LLC·Product code KPS·October 30, 2017
Revolution CT
FDA Recall
Completed
·GE Healthcare, LLC·Product code JAK·March 19, 2021
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Enforcement
Class II
·Completed·GE Healthcare, LLC·January 16, 2019
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781261 781262
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781347
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781270
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781260
FDA Recall
Completed
·Philips North America Llc·Product code LNH·August 11, 2021
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Recall
Completed
·Fresenius Medical Care Holdings, Inc.·Product code FKX·September 12, 2020