Recall Register

Philips North America Llc: FDA recalls

FDA enforcement reports name Philips North America Llc as the recalling firm in 129 events. The events have 410 product records. The recalls started from 2017 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

129 events, newest first.

FDA enforcement events of Philips North America Llc
InitiatedProduct (first record)TypeClassRecordsStatus
7 Aug 2026Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.DeviceClass II4Ongoing
1 Jul 2026Cardiac Workstation 5000. Product Number: 860439.DeviceClass II2Ongoing
5 Jun 2026Philips 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.DeviceClass II1Ongoing
26 May 2026Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703ADeviceClass II2Ongoing
1 May 2026DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.DeviceClass II1Ongoing
7 Jan 2026Brilliance iCT; Product Code (REF): 728306;DeviceClass II4Ongoing
12 Dec 2025Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.DeviceClass II1Ongoing
31 Oct 2025IntelliVue MP2. Product Number: M8102A.DeviceClass II22Ongoing
29 Oct 2025Incisive CT; Software Version Number: 4.5, 5.0, 5.1;DeviceClass II2Ongoing
13 Aug 2025Philips 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: 728317DeviceClass II10Ongoing
29 May 2025Spectral CT. Computed tomography X-ray system.DeviceClass II1Ongoing
13 May 2025Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146DeviceClass II18Ongoing
7 Apr 2025Microstream 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…DeviceClass II1Ongoing
1 Apr 2025Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.DeviceClass II1Ongoing
10 Mar 2025Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.DeviceClass II2Ongoing
25 Feb 2025Zenition 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.DeviceClass II3Ongoing
15 Jan 2025IntelliBridge EC10 Module. Model Number: 865115DeviceClass II5Ongoing
20 Nov 2024Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216DeviceClass II1Ongoing
16 Nov 2024Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.DeviceClass II1Ongoing
4 Nov 2024Achieva TX Interventional Coil 3.0TDeviceClass II13Ongoing
3 Sep 2024Evolution 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) 782143DeviceClass II13Ongoing
28 Jun 2024IntelliVue 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.DeviceClass II4Ongoing
5 Jun 2024SENSE 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.DeviceClass I3Ongoing
22 May 2024Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.DeviceClass II1Ongoing
3 May 2024Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343DeviceClass II30Ongoing
3 May 2024HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006411DeviceClass II3Ongoing
22 Apr 2024Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116DeviceClass II2Ongoing
19 Apr 2024Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.DeviceClass II1Ongoing
15 Apr 2024Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143DeviceClass II2Ongoing
29 Mar 2024The Oncology Essentials Package of the Spectral CT imaging system.DeviceClass II1Ongoing
22 Mar 2024Philips 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: SCL500RMI1UDeviceClass II1Ongoing
12 Mar 2024Achieva 1.5T, Magnetic Resonance System.DeviceClass II41Ongoing
15 Feb 2024DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126DeviceClass II1Ongoing
30 Nov 2023Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.DeviceClass II1Ongoing
17 Nov 2023Panorama 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.DeviceClass I1Ongoing
23 Oct 2023Achieva 1.5TDeviceClass II7Ongoing
9 Oct 2023Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.DeviceClass II3Ongoing
21 Sep 2023CombiDiagnost R90, Radiography and Fluoroscopy (R/F) systemDeviceClass II10Ongoing
31 Aug 2023EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380DeviceClass II2Ongoing
17 Aug 2023Patient 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: 867154DeviceClass II1Ongoing
14 Jun 2023IntelliVue 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…DeviceClass II1Ongoing
19 May 2023DigitalDiagnost C90, Model No. 712034 and 712035DeviceClass II1Ongoing
17 Mar 2023Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333DeviceClass II1Ongoing
9 Mar 2023Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201DeviceClass II2Ongoing
6 Mar 2023EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359DeviceClass II2Ongoing
22 Nov 2022Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137DeviceClass II5Ongoing
21 Nov 2022Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631DeviceClass II1Ongoing
21 Oct 2022Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) systemDeviceClass II1Ongoing
6 Sep 2022MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.DeviceClass II1Ongoing
29 Mar 2022The 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.…DeviceClass II1Completed
25 Feb 2022DigitalDiagnost C50 1.1DeviceClass II1Ongoing
22 Feb 2022Philips 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.DeviceClass II1Terminated
7 Feb 2022The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.DeviceClass II1Ongoing
4 Feb 2022Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORSDeviceClass II2Ongoing
2 Feb 2022Philips 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: R2.0DeviceClass II1Ongoing
3 Jan 2022eCareManager 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…DeviceClass II1Terminated
29 Nov 2021Infant Heel Warmers w/strap, Reference # 989805603201 1223DeviceClass II4Ongoing
26 Nov 2021Infa-Therm Transport Mattress, Reference Number 989805616831 1015DeviceClass II1Ongoing
24 Nov 2021Philips 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,…DeviceClass II2Ongoing
19 Nov 2021Philips 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.DeviceClass II1Terminated
12 Nov 2021Philips 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, 722224DeviceClass II1Terminated
12 Nov 2021BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075DeviceClass II3Ongoing
29 Oct 2021Wireless 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,…DeviceClass II1Ongoing
21 Oct 2021CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031DeviceClass II2Ongoing
24 Sep 2021Philips 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,…DeviceClass II1Terminated
13 Aug 2021The 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…DeviceClass II3Terminated
11 Aug 2021Ingenia 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 781396DeviceClass II12Completed
30 Jul 2021Ingenia 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: 781315DeviceClass II7Terminated
16 Jul 2021Philips, 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 defibrillatorDeviceClass II1Terminated
8 Jun 2021728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT UpgradesDeviceClass II5Terminated
1 May 2021Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201DeviceClass II12Ongoing
1 May 2021Continuous 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.DeviceClass II5Ongoing
23 Apr 2021Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition XDeviceClass II2Ongoing
13 Apr 2021BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306DeviceClass II1Terminated
29 Mar 2021Philips 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…DeviceClass II1Ongoing
23 Mar 2021Philips 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,…DeviceClass II1Terminated
22 Feb 2021Incisive CT Computed Tomography X-ray System Model: 728143DeviceClass II1Terminated
9 Feb 2021Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861ADeviceClass II4Ongoing
2 Feb 2021IntelliVue 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.DeviceClass II1Terminated
19 Nov 2020Emission 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.DeviceClass II1Terminated
18 Nov 2020Philips 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…DeviceClass II2Terminated
14 Sep 2020Philips 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…DeviceClass II2Terminated
16 Jul 2020Philips 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…DeviceClass II1Terminated
30 Jun 2020IntelliVue MX800 patient monitor, model no. 865240DeviceClass II2Terminated
25 Jun 2020IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173DeviceClass II1Ongoing
18 Jun 2020Phillips 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.DeviceClass II3Terminated
8 Jun 2020Philips 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)DeviceClass II1Terminated
2 Jun 2020EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.DeviceClass II1Terminated
19 May 2020Philips 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.DeviceClass II1Terminated
27 Apr 2020Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.DeviceClass II1Terminated
23 Apr 2020ProxiDiagnost N90, UDI 706100DeviceClass II1Terminated
21 Apr 2020Philips 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 defibrillationDeviceClass II1Terminated
20 Apr 2020Philips 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…DeviceClass II1Terminated
13 Apr 2020Philips 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…DeviceClass II1Terminated
13 Apr 2020Cardiovascular 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…DeviceClass II2Terminated
10 Apr 2020HeartStart 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…DeviceClass II1Terminated
10 Apr 2020Philips 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.DeviceClass II2Terminated
7 Apr 2020Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.DeviceClass II1Terminated
6 Apr 2020Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848DeviceClass II3Terminated
3 Apr 2020Philips 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: 722079DeviceClass II1Terminated
5 Mar 2020Phillips 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.DeviceClass II1Terminated
5 Mar 2020TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861DeviceClass II2Terminated
26 Feb 2020HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.DeviceClass II1Terminated
20 Feb 2020Expression 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…DeviceClass II1Terminated
14 Jan 2020Ambulance 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.DeviceClass II1Terminated
13 Jan 2020Philips 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 -…DeviceClass II1Terminated
30 Dec 2019Allura 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.DeviceClass II9Terminated
23 Dec 2019VesselNavigator 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…DeviceClass II1Terminated
20 Nov 2019ProxiDiagnost N90DeviceClass II1Terminated
16 Oct 2019HeartStart XL+ Defibrillator/Monitor, Model 861290DeviceClass II1Terminated
3 Oct 2019HeartStart XL+ Defibrillator/Monitor, Model 861290DeviceClass II1Terminated
10 Sep 2019Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017DeviceClass II2Terminated
23 Aug 2019IntelliVue 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…DeviceClass II1Terminated
19 Jul 2019Philips 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 configurationDeviceClass II1Terminated
16 Jul 2019Philips 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…DeviceClass II1Terminated
16 Jul 2019HeartStart 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…DeviceClass II1Terminated
7 Jun 2019Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9DeviceClass II1Terminated
29 Apr 2019Philips 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…DeviceClass III2Terminated
19 Apr 2019SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).DeviceClass II8Ongoing
28 Mar 2019IntelliVue 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…DeviceClass II4Ongoing
12 Mar 2019Azurion FlexArm, 722079DeviceClass II1Terminated
28 Feb 2019MultiDiagnost-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:…DeviceClass II5Terminated
25 Jan 2019Fetal Spiral Electrode, Model No. 9898 031 37631DeviceClass II1Terminated
25 Jan 2019Lithium-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…DeviceClass II1Terminated
9 Jan 2019PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patientsDeviceClass II9Ongoing
23 Nov 2018HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.DeviceClass II1Terminated
8 Aug 2018Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758DeviceClass II1Terminated
12 Jul 2017MRx 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…DeviceClass I1Terminated
24 Feb 2017HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9DeviceClass I1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Philips North America Llc: events for each product type
TypeEvents
Device129
Philips North America Llc: events in each class
ClassEvents
Class II124
Class I4
Class III1
Share of the events of the firm in Class I
3%
Share of all events on the register in Class I
18%
Events with the status Ongoing
68

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Philips North America Llc, by the year that the recall started. The largest year is 2020, with 27 events.

Official channels

Cite this page

Recall Register. Philips North America Llc: FDA recalls. https://recallregister.com/firm/philips-north-america-llc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA, WA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Philips North America Llc have?
Class II: 124 events. Class I: 4 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Philips North America Llc?
FDA event 99784, which the firm started on 7 Aug 2026. The first product in the record is: Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
How many FDA recalls of Philips North America Llc have the status Ongoing?
68 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.