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All Recalls

Every Philips Electronics North America Corporation Recall

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

99 recalls
High RiskFDA
Philips Electronics North America Corporation
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 4535644...
Medical Devices·651 affected·Nov 15, 2018
High RiskFDA
Philips Electronics North America Corporation
AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications i...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includi...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications ...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications incl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications in...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging appl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications in...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging app...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging appl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applica...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications i...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging appl...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imagin...
Cardiac Devices·5,115 affected·Jul 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 86...
Medical Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients...
Cardiac Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professional...
Medical Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor is for use by he...
Medical Devices·96,324 affected·Jul 13, 2018
High RiskFDA
Philips Electronics North America Corporation
HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearab...
Cardiac Devices·5 affected·May 3, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Medical Devices·4,488 affected·Apr 30, 2018
High RiskFDA
Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Medical Devices·25,499 affected·Apr 30, 2018
High RiskFDA
Philips Electronics North America Corporation
T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic imag...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Mul...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic ima...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, sp...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectrosc...
Diagnostic Devices·8,205 affected·Mar 16, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product...
Medical Implants·682 affected·Mar 14, 2018
RecallFDA
Philips Electronics North America Corporation
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel train...
Cardiac Devices·4,315 affected·Feb 7, 2018
High RiskFDA
Philips Electronics North America Corporation
Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated...
Cardiac Devices·28,094 affected·Jan 29, 2018
CriticalFDA
Philips Electronics North America Corporation
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper s...
Medical Implants·705 affected·Jan 4, 2018
High RiskFDA
Philips Electronics North America Corporation
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PI...
Medical Devices·20,357 affected·Jan 3, 2018
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd fo...
Medical Implants·1,486 affected·Dec 20, 2017
High RiskFDA
Philips Electronics North America Corporation
IntelliVue X3 Patient Monitor.
Medical Devices·975 affected·Nov 17, 2017
RecallFDA
Philips Electronics North America Corporation
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
Medical Devices·1,079 affected·Sep 20, 2017
High RiskFDA
Philips Electronics North America Corporation
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient...
Medical Devices·7,071 affected·Aug 23, 2017
High RiskFDA
Philips Electronics North America Corporation
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as P...
Cardiac Devices·15,811 affected·Jul 17, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnos...
Diagnostic Devices·98 affected·May 31, 2017
High RiskFDA
Philips Electronics North America Corporation
Philips DigitalDiagnost 3.1.x X-Ray System
Diagnostic Devices·132 affected·May 11, 2017
CriticalFDA
Philips Electronics North America Corporation
NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
Medical Devices·9,120 affected·May 4, 2017