| 7 Aug 2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311. | Device | Class II | 4 | Ongoing |
| 1 Jul 2026 | Cardiac Workstation 5000. Product Number: 860439. | Device | Class II | 2 | Ongoing |
| 5 Jun 2026 | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX. | Device | Class II | 1 | Ongoing |
| 26 May 2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Device | Class II | 2 | Ongoing |
| 1 May 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | Device | Class II | 1 | Ongoing |
| 7 Jan 2026 | Brilliance iCT; Product Code (REF): 728306; | Device | Class II | 4 | Ongoing |
| 12 Dec 2025 | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | Device | Class II | 1 | Ongoing |
| 31 Oct 2025 | IntelliVue MP2. Product Number: M8102A. | Device | Class II | 22 | Ongoing |
| 29 Oct 2025 | Incisive CT; Software Version Number: 4.5, 5.0, 5.1; | Device | Class II | 2 | Ongoing |
| 13 Aug 2025 | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317 | Device | Class II | 10 | Ongoing |
| 29 May 2025 | Spectral CT. Computed tomography X-ray system. | Device | Class II | 1 | Ongoing |
| 13 May 2025 | Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146 | Device | Class II | 18 | Ongoing |
| 7 Apr 2025 | Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity… | Device | Class II | 1 | Ongoing |
| 1 Apr 2025 | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. | Device | Class II | 1 | Ongoing |
| 10 Mar 2025 | Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. | Device | Class II | 2 | Ongoing |
| 25 Feb 2025 | Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the devices. | Device | Class II | 3 | Ongoing |
| 15 Jan 2025 | IntelliBridge EC10 Module. Model Number: 865115 | Device | Class II | 5 | Ongoing |
| 20 Nov 2024 | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | Device | Class II | 1 | Ongoing |
| 16 Nov 2024 | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | Device | Class II | 1 | Ongoing |
| 4 Nov 2024 | Achieva TX Interventional Coil 3.0T | Device | Class II | 13 | Ongoing |
| 3 Sep 2024 | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143 | Device | Class II | 13 | Ongoing |
| 28 Jun 2024 | IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. | Device | Class II | 4 | Ongoing |
| 5 Jun 2024 | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352. | Device | Class I | 3 | Ongoing |
| 22 May 2024 | Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate. | Device | Class II | 1 | Ongoing |
| 3 May 2024 | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343 | Device | Class II | 30 | Ongoing |
| 3 May 2024 | HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411 | Device | Class II | 3 | Ongoing |
| 22 Apr 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116 | Device | Class II | 2 | Ongoing |
| 19 Apr 2024 | Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. | Device | Class II | 1 | Ongoing |
| 15 Apr 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143 | Device | Class II | 2 | Ongoing |
| 29 Mar 2024 | The Oncology Essentials Package of the Spectral CT imaging system. | Device | Class II | 1 | Ongoing |
| 22 Mar 2024 | Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500RMI1U | Device | Class II | 1 | Ongoing |
| 12 Mar 2024 | Achieva 1.5T, Magnetic Resonance System. | Device | Class II | 41 | Ongoing |
| 15 Feb 2024 | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126 | Device | Class II | 1 | Ongoing |
| 30 Nov 2023 | Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System. | Device | Class II | 1 | Ongoing |
| 17 Nov 2023 | Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device. | Device | Class I | 1 | Ongoing |
| 23 Oct 2023 | Achieva 1.5T | Device | Class II | 7 | Ongoing |
| 9 Oct 2023 | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy. | Device | Class II | 3 | Ongoing |
| 21 Sep 2023 | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system | Device | Class II | 10 | Ongoing |
| 31 Aug 2023 | EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380 | Device | Class II | 2 | Ongoing |
| 17 Aug 2023 | Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essentials Expand Product Number: 867154 | Device | Class II | 1 | Ongoing |
| 14 Jun 2023 | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need… | Device | Class II | 1 | Ongoing |
| 19 May 2023 | DigitalDiagnost C90, Model No. 712034 and 712035 | Device | Class II | 1 | Ongoing |
| 17 Mar 2023 | Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333 | Device | Class II | 1 | Ongoing |
| 9 Mar 2023 | Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201 | Device | Class II | 2 | Ongoing |
| 6 Mar 2023 | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359 | Device | Class II | 2 | Ongoing |
| 22 Nov 2022 | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | Device | Class II | 5 | Ongoing |
| 21 Nov 2022 | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631 | Device | Class II | 1 | Ongoing |
| 21 Oct 2022 | Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system | Device | Class II | 1 | Ongoing |
| 6 Sep 2022 | MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162. | Device | Class II | 1 | Ongoing |
| 29 Mar 2022 | The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.… | Device | Class II | 1 | Completed |
| 25 Feb 2022 | DigitalDiagnost C50 1.1 | Device | Class II | 1 | Ongoing |
| 22 Feb 2022 | 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. | Device | Class II | 1 | Terminated |
| 7 Feb 2022 | The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641. | Device | Class II | 1 | Ongoing |
| 4 Feb 2022 | Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS | Device | Class II | 2 | Ongoing |
| 2 Feb 2022 | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0 | Device | Class II | 1 | Ongoing |
| 3 Jan 2022 | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of… | Device | Class II | 1 | Terminated |
| 29 Nov 2021 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 | Device | Class II | 4 | Ongoing |
| 26 Nov 2021 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 | Device | Class II | 1 | Ongoing |
| 24 Nov 2021 | Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027,… | Device | Class II | 2 | Ongoing |
| 19 Nov 2021 | Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028. | Device | Class II | 1 | Terminated |
| 12 Nov 2021 | Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224 | Device | Class II | 1 | Terminated |
| 12 Nov 2021 | BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075 | Device | Class II | 3 | Ongoing |
| 29 Oct 2021 | Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033,… | Device | Class II | 1 | Ongoing |
| 21 Oct 2021 | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031 | Device | Class II | 2 | Ongoing |
| 24 Sep 2021 | 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,… | Device | Class II | 1 | Terminated |
| 13 Aug 2021 | The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent… | Device | Class II | 3 | Terminated |
| 11 Aug 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 | Device | Class II | 12 | Completed |
| 30 Jul 2021 | Ingenia 1.5T Evoluton- 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: 781315 | Device | Class II | 7 | Terminated |
| 16 Jul 2021 | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator | Device | Class II | 1 | Terminated |
| 8 Jun 2021 | 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades | Device | Class II | 5 | Terminated |
| 1 May 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201 | Device | Class II | 12 | Ongoing |
| 1 May 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery. | Device | Class II | 5 | Ongoing |
| 23 Apr 2021 | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X | Device | Class II | 2 | Ongoing |
| 13 Apr 2021 | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 | Device | Class II | 1 | Terminated |
| 29 Mar 2021 | Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010 Rev B 453564483321 Flex… | Device | Class II | 1 | Ongoing |
| 23 Mar 2021 | Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066,… | Device | Class II | 1 | Terminated |
| 22 Feb 2021 | Incisive CT Computed Tomography X-ray System Model: 728143 | Device | Class II | 1 | Terminated |
| 9 Feb 2021 | Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A | Device | Class II | 4 | Ongoing |
| 2 Feb 2021 | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. | Device | Class II | 1 | Terminated |
| 19 Nov 2020 | Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. | Device | Class II | 1 | Terminated |
| 18 Nov 2020 | Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital… | Device | Class II | 2 | Terminated |
| 14 Sep 2020 | Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop… | Device | Class II | 2 | Terminated |
| 16 Jul 2020 | Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and… | Device | Class II | 1 | Terminated |
| 30 Jun 2020 | IntelliVue MX800 patient monitor, model no. 865240 | Device | Class II | 2 | Terminated |
| 25 Jun 2020 | IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 | Device | Class II | 1 | Ongoing |
| 18 Jun 2020 | Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. | Device | Class II | 3 | Terminated |
| 8 Jun 2020 | Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036) | Device | Class II | 1 | Terminated |
| 2 Jun 2020 | EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. | Device | Class II | 1 | Terminated |
| 19 May 2020 | Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation. | Device | Class II | 1 | Terminated |
| 27 Apr 2020 | Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation. | Device | Class II | 1 | Terminated |
| 23 Apr 2020 | ProxiDiagnost N90, UDI 706100 | Device | Class II | 1 | Terminated |
| 21 Apr 2020 | Philips HeartStart XL Monitor/Defibrillators 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 | Device | Class II | 1 | Terminated |
| 20 Apr 2020 | Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to transmit a controlled electrical shock from an… | Device | Class II | 1 | Terminated |
| 13 Apr 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… | Device | Class II | 1 | Terminated |
| 13 Apr 2020 | Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring… | Device | Class II | 2 | Terminated |
| 10 Apr 2020 | HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life… | Device | Class II | 1 | Terminated |
| 10 Apr 2020 | Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. | Device | Class II | 2 | Terminated |
| 7 Apr 2020 | Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography. | Device | Class II | 1 | Terminated |
| 6 Apr 2020 | Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848 | Device | Class II | 3 | Terminated |
| 3 Apr 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 | Device | Class II | 1 | Terminated |
| 5 Mar 2020 | Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. | Device | Class II | 1 | Terminated |
| 5 Mar 2020 | TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861 | Device | Class II | 2 | Terminated |
| 26 Feb 2020 | HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9. | Device | Class II | 1 | Terminated |
| 20 Feb 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… | Device | Class II | 1 | Terminated |
| 14 Jan 2020 | Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments. | Device | Class II | 1 | Terminated |
| 13 Jan 2020 | Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Configuration - 453564067171 96-Hour Configuration -… | Device | Class II | 1 | Terminated |
| 30 Dec 2019 | Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator. | Device | Class II | 9 | Terminated |
| 23 Dec 2019 | VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura… | Device | Class II | 1 | Terminated |
| 20 Nov 2019 | ProxiDiagnost N90 | Device | Class II | 1 | Terminated |
| 16 Oct 2019 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Device | Class II | 1 | Terminated |
| 3 Oct 2019 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Device | Class II | 1 | Terminated |
| 10 Sep 2019 | Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 | Device | Class II | 2 | Terminated |
| 23 Aug 2019 | IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded twisted pair data cable bundle and is a component of the Philips Remote Antenna (PN 867151). The Remote Antenna is used with IntelliVue MX40 Patient Worn Monitors in the USA, to… | Device | Class II | 1 | Terminated |
| 19 Jul 2019 | Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration | Device | Class II | 1 | Terminated |
| 16 Jul 2019 | Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used… | Device | Class II | 1 | Terminated |
| 16 Jul 2019 | HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed… | Device | Class II | 1 | Terminated |
| 7 Jun 2019 | Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 | Device | Class II | 1 | Terminated |
| 29 Apr 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… | Device | Class III | 2 | Terminated |
| 19 Apr 2019 | SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). | Device | Class II | 8 | Ongoing |
| 28 Mar 2019 | IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center… | Device | Class II | 4 | Ongoing |
| 12 Mar 2019 | Azurion FlexArm, 722079 | Device | Class II | 1 | Terminated |
| 28 Feb 2019 | MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas:… | Device | Class II | 5 | Terminated |
| 25 Jan 2019 | Fetal Spiral Electrode, Model No. 9898 031 37631 | Device | Class II | 1 | Terminated |
| 25 Jan 2019 | Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple… | Device | Class II | 1 | Terminated |
| 9 Jan 2019 | PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients | Device | Class II | 9 | Ongoing |
| 23 Nov 2018 | HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators. | Device | Class II | 1 | Terminated |
| 8 Aug 2018 | Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 | Device | Class II | 1 | Terminated |
| 12 Jul 2017 | 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… | Device | Class I | 1 | Terminated |
| 24 Feb 2017 | HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 | Device | Class I | 1 | Terminated |