Philips North America, LLC
273 recalls on record · Latest: Dec 10, 2025
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Mod…
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brill…
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Powe…
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
FDA Devices Moderate Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity C…
FDA Devices Moderate Jun 16, 2021
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
FDA Devices Moderate Jun 9, 2021
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
FDA Devices Moderate Jun 2, 2021
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and …
FDA Devices Moderate Apr 7, 2021
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of a…
FDA Devices Moderate Feb 3, 2021
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
FDA Devices Moderate Jan 20, 2021
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of r…
FDA Devices Moderate Dec 16, 2020
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple phys…
FDA Devices Moderate Nov 4, 2020
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to…
FDA Devices Moderate Oct 7, 2020
ProxiDiagnost N90
FDA Devices Moderate Aug 26, 2020
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitoring System (…
FDA Devices Moderate Aug 26, 2020
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI Patient Moni…
FDA Devices Moderate Aug 26, 2020
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring Syst…
FDA Devices Moderate Aug 19, 2020
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536…
FDA Devices Moderate Jul 29, 2020
IntelliVue MX800 patient monitor, model no. 865240
FDA Devices Moderate Jul 15, 2020
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
FDA Devices Moderate Jun 17, 2020
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02),…
FDA Devices Moderate Jun 10, 2020
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration…
FDA Devices Moderate Jun 3, 2020
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained…
FDA Devices Moderate Jun 3, 2020
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A…
FDA Devices Moderate Jun 3, 2020
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricul…
FDA Devices Moderate May 27, 2020
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained …
FDA Devices Moderate May 27, 2020
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: …
FDA Devices Moderate May 20, 2020
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interven…
FDA Devices Moderate May 20, 2020
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interven…
FDA Devices Moderate May 13, 2020
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
FDA Devices Moderate May 13, 2020
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
FDA Devices Moderate May 6, 2020
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoro…
FDA Devices Moderate May 6, 2020
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
FDA Devices Moderate Apr 8, 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 …
FDA Devices Moderate Mar 25, 2020
Integris Allura 9, system codes 722018 722021
FDA Devices Moderate Mar 25, 2020
Cardio Vascular-Allura Centron, system code 722400
FDA Devices Moderate Mar 25, 2020
UroDiagnost Eleva, system code 708033
FDA Devices Moderate Mar 25, 2020
OmniDiagnost Eleva System codes 708028 708027
FDA Devices Moderate Mar 25, 2020
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
FDA Devices Moderate Mar 25, 2020
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M35…
FDA Devices Moderate Mar 25, 2020
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Devices Moderate Mar 25, 2020
Poly G Integris H5000, System code 72246
FDA Devices Moderate Mar 4, 2020
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Se…
FDA Devices Moderate Mar 4, 2020
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be u…
FDA Devices Moderate Feb 26, 2020
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
FDA Devices Moderate Feb 26, 2020
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
FDA Devices Moderate Dec 11, 2019