404 results
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58ms
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Sources: EU EUDAMED, US FDA
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Ingenia 3.0T-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 Number: 781342
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Ingenia Elition S-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 Number: 781357 (OUS)
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Achieva 3.0T-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 Number: 781277 (OUS)
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Ingenia CX 3.0T-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 Number: 78127 (OUS)
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
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
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
FDA Recall
Terminated
·Philips North America Llc·Product code JAK·June 8, 2021
728332 IQon Spectral CT-Computed Tomography X-ray system
FDA Recall
Terminated
·Philips North America Llc·Product code JAK·June 8, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·May 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·May 1, 2021
Ingenia 1.5T-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 Number: 781341
FDA Recall
Terminated
·Philips North America Llc·Product code LNH·July 30, 2021
Infant Heel Warmers w/strap, Reference # 989805603201 1223
FDA Recall
Open, Classified
·Philips North America Llc·Product code IMD·November 29, 2021
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
FDA Recall
Open, Classified
·Philips North America Llc·Product code IMD·November 29, 2021
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
FDA Recall
Terminated
·Philips North America Llc·Product code MWI·February 22, 2022
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAA·September 21, 2023
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAA·September 21, 2023
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
FDA Recall
Open, Classified
·Philips North America Llc·Product code KPR·September 21, 2023
The Oncology Essentials Package of the Spectral CT imaging system.
FDA Recall
Open, Classified
·Philips North America Llc·Product code JAK·March 29, 2024
Ingenia 3.0T, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024
Intera 1.5T Power/Pulsar, Magnetic Resonance System.
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·March 12, 2024