190 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
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
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
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
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
FDA Recall
Terminated
·Philips North America, LLC·Product code JAK·April 6, 2020
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
FDA Recall
Terminated
·Philips North America, LLC·Product code OWB·April 3, 2020
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician.
FDA Recall
Terminated
·Philips North America, LLC·Product code MKJ·April 13, 2020
IntelliVue MX700 patient monitor, model no. 865241
FDA Recall
Terminated
·Philips North America, LLC·Product code MHX·June 30, 2020
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monitoring Systems is intended for use by healthcare professionals to monitor vital signs of patients undergoing MRI procedures and to provide signals for the synchronization of the MRI scanner.
FDA Recall
Terminated
·Philips North America, LLC·Product code MWI·February 20, 2020
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
FDA Recall
Terminated
·Philips North America LLC·Product code MKJ·September 10, 2019
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
FDA Recall
Terminated
·Philips North America, LLC·Product code MHX·April 29, 2019
HeartStart XL+ Defibrillator/Monitor, Model 861290
FDA Recall
Terminated
·Philips North America, LLC·Product code MKJ·October 16, 2019
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)
FDA Recall
Terminated
·Philips North America Llc·Product code JAA·September 24, 2021
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
FDA Recall
Terminated
·Philips North America, LLC·Product code MKJ·July 12, 2017
Poly G Integris H5000, System code 72246
FDA Recall
Terminated
·Philips North America, LLC·Product code IZI·December 30, 2019
Cardio Vascular-Allura Centron, system code 722400
FDA Recall
Terminated
·Philips North America, LLC·Product code OWB·December 30, 2019