658 results
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Sources: EU EUDAMED, US FDA
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Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
FDA Enforcement
Class II
·Completed·Shimadzu Medical Systems·July 22, 2020
Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology.
FDA Recall
Completed
·Shimadzu Medical Systems·Product code OWB·November 4, 2019
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
FDA Enforcement
Class II
·Completed·Siemens Medical Solutions USA, Inc·July 4, 2018
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023
AggreGuide A-100 Instrument
FDA Recall
Completed
·Aggredyne, Inc.·Product code JOZ·July 23, 2019
LYFO Disk
FDA Recall
Completed
·Microbiologics Inc·Product code JTR·July 17, 2015
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
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Recall
Completed
·Accuray Incorporated·Product code IYE·August 3, 2023
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
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
FDA Recall
Completed
·Philips Ultrasound Inc·Product code IYN·July 22, 2021