Brand

Philips North America, Llc Recalls

260 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Philips North America, Llc.

260Total Recalls
34Critical
46.6MUnits Affected
Jan 7, 2026Most Recent
All Recalls

Every Philips North America, Llc Recall

Sorted by most recent. Click any recall for full details.

260 recalls
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or ...
Medical Devices·3 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Medical Devices·1,301 affected·May 1, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X
Diagnostic Devices·156 affected·Apr 23, 2021
High RiskFDA
Philips North America Llc
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Medical Devices·2 affected·Apr 13, 2021
High RiskFDA
Philips North America, Llc
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological par...
Medical Devices·31,773 affected·Mar 23, 2021
High RiskFDA
Philips North America Llc
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Cardiac Devices·15 affected·Feb 9, 2021
High RiskFDA
Philips North America Llc
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Cardiac Devices·6 affected·Feb 9, 2021
High RiskFDA
Philips North America Llc
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for mon...
Medical Devices·3 affected·Feb 2, 2021
High RiskFDA
Philips North America, Llc
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for de...
Medical Devices·2,714 affected·Nov 19, 2020
High RiskFDA
Philips North America Llc
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, m...
Medical Devices·2 affected·Nov 18, 2020
High RiskFDA
Philips North America, Llc
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used...
Cardiac Devices·8,942 affected·Sep 14, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3...
Cardiac Devices·95,212 affected·Jul 16, 2020
High RiskFDA
Philips North America, Llc
IntelliVue MX800 patient monitor, model no. 865240
Medical Devices·28 affected·Jun 30, 2020
High RiskFDA
Philips North America, Llc
Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the Expression MR400 MRI Patient Monitor...
Medical Devices·9,705 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used in the Expression MR400 MRI ...
Medical Devices·24,545 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Mon...
Medical Devices·118 affected·Jun 18, 2020
High RiskFDA
Philips North America, Llc
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
Diagnostic Devices·52 affected·Jun 2, 2020
High RiskFDA
Philips North America, Llc
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen satura...
Respiratory Devices·1 affected·May 19, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination ...
Cardiac Devices·260 affected·Apr 27, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical perso...
Cardiac Devices·130 affected·Apr 21, 2020
High RiskFDA
Philips North America, Llc
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switch...
Cardiac Devices·21,683 affected·Apr 20, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical person...
Cardiac Devices·94,034 affected·Apr 13, 2020
High RiskFDA
Philips North America, Llc
Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows,...
Diagnostic Devices·1,075 affected·Apr 13, 2020
High RiskFDA
Philips North America, Llc
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnost...
Surgical Devices·25 affected·Apr 10, 2020
High RiskFDA
Philips North America, Llc
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Pro...
Cardiac Devices·8 affected·Apr 10, 2020
High RiskFDA
Philips North America, Llc
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnost...
Surgical Devices·25 affected·Apr 10, 2020
High RiskFDA
Philips North America, Llc
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Diagnostic Devices·346 affected·Apr 7, 2020
High RiskFDA
Philips North America, Llc
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Medical Devices·2 affected·Apr 6, 2020
High RiskFDA
Philips North America, Llc
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Medical Devices·19 affected·Apr 6, 2020
High RiskFDA
Philips North America, Llc
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Intervent...
Medical Devices·22 affected·Apr 3, 2020
High RiskFDA
Philips North America, Llc
TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
Medical Devices·81,626 affected·Mar 5, 2020
CriticalFDA
Philips North America, Llc
HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, ...
Cardiac Devices·97,788 affected·Feb 26, 2020
High RiskFDA
Philips North America, Llc
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.0...
Medical Devices·2,214 affected·Feb 20, 2020
High RiskFDA
Philips North America, Llc
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is inte...
Cardiac Devices·43 affected·Jan 14, 2020
High RiskFDA
Philips North America, Llc
Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different config...
Medical Devices·44,442 affected·Jan 13, 2020
High RiskFDA
Philips North America, Llc
Integris Allura 9, system codes 722018 722021
Medical Devices·20 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Cardio Vascular-Allura Centron, system code 722400
Medical Devices·87 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
UroDiagnost Eleva, system code 708033
Diagnostic Devices·4 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
OmniDiagnost Eleva System codes 708028 708027
Diagnostic Devices·69 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Medical Devices·70 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Diagnostic Devices·534 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Poly G Integris H5000, System code 72246
Medical Devices·1 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
ProxiDiagnost N90
Diagnostic Devices·71 affected·Nov 20, 2019
High RiskFDA
Philips North America, Llc
HeartStart XL+ Defibrillator/Monitor, Model 861290
Cardiac Devices·23,749 affected·Oct 16, 2019
High RiskFDA
Philips North America, Llc
HeartStart XL+ Defibrillator/Monitor, Model 861290
Cardiac Devices·24,738 affected·Oct 3, 2019
High RiskFDA
Philips North America Llc
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Cardiac Devices·96 affected·Sep 10, 2019
High RiskFDA
Philips North America Llc
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Cardiac Devices·44 affected·Sep 10, 2019
High RiskFDA
Philips North America, Llc
IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coax and unshielded ...
Medical Devices·1,790 affected·Aug 23, 2019