FDA Device Recalls

Recalls / Firms / Philips Healthcare Inc.

Philips Healthcare Inc.

149 FDA device recalls on record.

DateClassProductReason
2013-08-08Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnos
2013-07-08Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part N
2013-06-19Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC
2013-06-11Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage
2013-04-08HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M353
2013-03-05Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026;
2013-01-28Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended f
2013-01-16Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032,
2013-01-16Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712
2013-01-16Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062
2013-01-16Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applic
2013-01-16Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712
2013-01-14Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS
2012-12-13Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Univ
2012-11-28Mobile Diagnostic X-Ray System with Digital Panel
2012-11-09Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The inte
2012-10-30Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ra
2012-10-30Philips Digital Diagnost Stationary radiographic system
2012-10-25Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712
2012-09-12Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 0
2012-09-11Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Star
2012-09-06Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector
2012-08-15Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277,
2012-08-14Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digit
2012-07-25Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a mu
2012-07-11Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031,
2012-07-11Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X
2012-06-20Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6
2012-06-20Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3
2012-06-20Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for
2012-06-14Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xce
2012-05-22Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Statio
2012-05-21Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva
2012-05-11Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
2012-05-02Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independe
2012-04-03Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use:
2012-04-02Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
2012-02-14Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034
2012-02-09Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recordin
2012-01-09MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Us
2012-01-09Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The
2011-12-26DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional diagnostic X-Ra
2011-11-19Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography syst
2011-11-01Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic system,
2011-10-19Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
2011-10-04Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-r
2011-10-04Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usage:
2011-10-04Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usage: F
2011-09-01MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application th
2011-07-27PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A comp
2011-07-08Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Cli
2011-07-08Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR tabl
2011-06-10Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564041261,
2011-06-10Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part Numbers VM4 863063, 453564
2011-05-03Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Informat
2011-04-18Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifuncti
2011-04-07Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These products
2011-04-07Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used wit
2011-04-01Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an option for dig
2011-03-16Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue Clinical In
2011-02-07Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or
2011-01-17BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnostic Radio
2010-12-17Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.
2010-11-10The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav
2010-10-19Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Versio
2010-08-31Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals whenever
2010-08-31Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals whenever t
2010-07-21Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds
2010-07-21Philips M1026BT Gas Modules with manifolds
2010-07-21Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds
2010-07-21Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds
2010-07-16HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartStart MRx i
2010-06-28Philips Intellivue Patient Monitor Model MP70 (M8007A)
2010-06-28Philips Intellivue Patient Monitor Model MP60 (M8005A)
2010-05-06HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/defibrillat
2010-04-07HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx Defibrillator Monitor, Model M3536
2010-04-05Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomograp
2010-03-04HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt
2010-01-19Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx
2009-11-23Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A.
2009-11-23Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A.
2009-11-23Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A.
2009-11-23Philips Avalon Fetal Monitor FM 40 Catalog Number: M2704A.
2009-11-19Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products. Intended to be used for moni
2009-11-19100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The intended use i
2009-11-19French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac output monitoring
2009-11-19100-120V Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring end tidal
2009-11-19French 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous,
2009-11-19NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output monitoring
2009-11-19515B Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to provide continuous, non
2009-11-19NICO2, Model 7600 Respironics/Philips Product. Intended use is cardiac output monitoring via the m
2009-11-19Spanish 100-120V TCOM-860, Respironics/Philips product. Used for trending O2 and CO2 tension at the
2009-11-19515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product. Intended use is to provide continuo
2009-11-19515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous, non-invasive mon
2009-11-19HeartStart MRx- AC power module kit. For use for the termination of ventricular tachycardia and ven
2009-11-19100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned product. Intended use is to provid
2009-11-19Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned product. Intended use is to provide
2009-11-19Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended use is to provide continuous,
2009-11-19100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product. Intended use is to provide continuo
2009-11-19100-120V 515B with RS-232 Pulse Oximeter - Dixtal owned product. Intended use is to provide continu
2009-11-19Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips product. Intended use of the monito
2009-11-19Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product. Intended use is to provide continuo
2009-11-19Transcutaneous C02 & 02 Monitor - 860, Refurbished, Respironics/Philips product. Used for trending
2009-11-19100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned product. Intended use is to prov
2009-11-19100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished - Dixtal owned product. Intended use
2009-11-19TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to provide short ter
2009-11-19Tidal Wave Sp Model 715, Respironics/Philips product. Intended use of the monitors is to provide sh
2009-11-19Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended use of the monitors is to prov
2009-11-19Tidal Wave Model 615, Respironics/Philips product. Intended use of the monitors is to provide short
2009-11-19NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output monitorin
2009-11-19Evaluation Kit, LOFLO Engine, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sensor
2009-11-19Spanish Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring end tidal C
2009-11-19C5 LOFLO Evaluation Kit, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sensor is to
2009-11-19100-120V 2001 Pulse Oximeter With Mars - Dixtal owned product. Intended use is to provide continuou
2009-11-19Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished, Respironics/Philips product. Intended to be use
2009-11-19Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product. Intended to be used for moni
2009-11-19100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is cardiac output
2009-11-19DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices including urime
2009-11-19Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometric, carbon
2009-11-19Tidal wave, Model 610, Respironics/Philips product. Intended use of the monitors is to provide shor
2009-11-19Japanese TidalWave SP 715, Respironics/Philips product. Intended use of the monitors is to provide
2009-11-19Tidal Wave 610, Refurbished, Respironics/Philips product. Intended use of the monitors is to provid
2009-11-19Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric, carbon
2009-11-19AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Philips produc
2009-11-19Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac output monitoring
2009-11-19French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product. Used for trending O2 and CO2
2009-11-19Sharn TidalGuard SP 710V, Respironics/Philips product. Intended use of the monitors is to provide s
2009-11-19100-120V Capnogard 1265, Refurbished, Respironics/Philips product. Intended to be used for monitori
2009-11-19HeartStart MRx Defibrillator/Monitor. For use for the termination of ventricular tachycardia and ve
2009-11-19Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips product. Used to provide spirom
2009-11-19Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending O2 and CO2 te
2009-11-19100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned product. Intended use is to pro
2009-11-19REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of the monitor
2009-11-19Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended use of the Capnostat 5 CO2 senso
2009-11-19Japanese TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to provide
2009-11-19Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product. Intended use is to provide co
2009-11-12Philips HeartStart Vehicle Wall Mount, Model M5528A with Philips HeartStart DC Power Module, Model
2009-10-30SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM mon
2009-10-30SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predi
2009-10-30SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Pa
2009-10-21IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended fo
2009-08-21HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the te
2009-07-07HeartStart MRx/MRxE Defibrillator/Monitor Models: M3536A (HeartStart MRx) and M3536J (HeartStart MR
2009-05-12Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
2009-05-12Philips Avalon Fetal Monitor FM20; Model Number: M2702A.
2009-05-05Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection,
2009-05-05CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and man
2009-04-10HeartStart MRx Defibrillator/Monitor, M3535A/M3536A Is used for the termination of ventricular tac
2009-03-30HeartStart XL Model M4735A Defibrillator, Automatic, External Defibrillator-Monitor. The defibrill