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Philips Healthcare Inc.

148 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgra recall (Z-1783-2014)Philips Healthcare Inc.2014-06-11
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures fo recall (Z-2059-2013)Philips Healthcare Inc.2013-08-26
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Produ recall (Z-1964-2013)Philips Healthcare Inc.2013-08-21
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M recall (Z-1797-2013)Philips Healthcare Inc.2013-07-24
Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 recall (Z-1780-2013)Philips Healthcare Inc.2013-07-20
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 71 recall (Z-1447-2013)Philips Healthcare Inc.2013-06-17
Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 71 recall (Z-1448-2013)Philips Healthcare Inc.2013-06-17
Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 70 recall (Z-1449-2013)Philips Healthcare Inc.2013-06-17
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 70406 recall (Z-1450-2013)Philips Healthcare Inc.2013-06-17
HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M353 recall (Z-1189-2013)Philips Healthcare Inc.2013-04-29
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed recall (Z-1003-2013)Philips Healthcare Inc.2013-04-17
Philips Digital Diagnost Stationary radiographic system recall (Z-0900-2013)Philips Healthcare Inc.2013-03-01
Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 71202 recall (Z-0884-2013)Philips Healthcare Inc.2013-02-26
Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is in recall (Z-0871-2013)Philips Healthcare Inc.2013-02-21
Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 Su recall (Z-0824-2013)Philips Healthcare Inc.2013-02-14
Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscop recall (Z-0767-2013)Philips Healthcare Inc.2013-02-01
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Us recall (Z-0702-2013)Philips Healthcare Inc.2013-01-28
Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX recall (Z-0495-2013)Philips Healthcare Inc.2012-12-10
Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for ma recall (Z-0475-2013)Philips Healthcare Inc.2012-12-05
Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The He recall (Z-0011-2013)Philips Healthcare Inc.2012-10-04
Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from recall (Z-2494-2012)Philips Healthcare Inc.2012-09-28
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dua recall (Z-2465-2012)Philips Healthcare Inc.2012-09-27
Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic syste recall (Z-2384-2012)Philips Healthcare Inc.2012-09-14
Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M recall (Z-2347-2012)Philips Healthcare Inc.2012-09-10
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277 recall (Z-2303-2012)Philips Healthcare Inc.2012-08-30
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta D recall (Z-2207-2012)Philips Healthcare Inc.2012-08-15
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 70603 recall (Z-2208-2012)Philips Healthcare Inc.2012-08-15
Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: P recall (Z-2156-2012)Philips Healthcare Inc.2012-08-08
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart M recall (Z-1986-2012)Philips Healthcare Inc.2012-07-11
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Phi recall (Z-1942-2012)Philips Healthcare Inc.2012-07-05
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, an recall (Z-1896-2012)Philips Healthcare Inc.2012-06-27
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diag recall (Z-1829-2012)Philips Healthcare Inc.2012-06-20
Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system recall (Z-1821-2012)Philips Healthcare Inc.2012-06-18
Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror ic recall (Z-1818-2012)Philips Healthcare Inc.2012-06-15
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwi recall (Z-1538-2012)Philips Healthcare Inc.2012-06-13
Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains recall (Z-1689-2012)Philips Healthcare Inc.2012-05-30
Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Inte recall (Z-1464-2012)Philips Healthcare Inc.2012-04-26
Allura X-ray System. The Allura X-ray System is an angiographic X-ray system. recall (Z-1462-2012)Philips Healthcare Inc.2012-04-25
Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiogra recall (Z-1212-2012)Philips Healthcare Inc.2012-03-29
Philips Healthcare EasyDiagnost Eleva DRF 4.0 Stationary X-Ray System with DRF as an optio recall (Z-1178-2012)Philips Healthcare Inc.2012-03-27
DuoDiagnost, model 707015, Universal RF system Product Usage: is a mult-functional diagnos recall (Z-1220-2012)Philips Healthcare Inc.2012-03-16
Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Mod recall (Z-1216-2012)Philips Healthcare Inc.2012-03-15
Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recall (Z-1134-2012)Philips Healthcare Inc.2012-03-01
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Pro recall (Z-0985-2012)Philips Healthcare Inc.2012-02-08
Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usa recall (Z-0936-2012)Philips Healthcare Inc.2012-02-02
Philips Digital Diagnost Rel 3, a radiographic system, digital Intended use: Radiographic recall (Z-0313-2012)Philips Healthcare Inc.2011-11-30
Philips BV Pulsera Fluoroscopic Image Intensified X-ray Catalog Number: 718095 Product Usa recall (Z-0116-2012)Philips Healthcare Inc.2011-10-27
Philips BV Endura Fluoroscopic Image Intensified X-ray Catalog Number: 718074 Product Usag recall (Z-0117-2012)Philips Healthcare Inc.2011-10-27
Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscop recall (Z-0118-2012)Philips Healthcare Inc.2011-10-27
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software applic recall (Z-0032-2012)Philips Healthcare Inc.2011-10-07
PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc recall (Z-3205-2011)Philips Healthcare Inc.2011-09-14
Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 Inte recall (Z-3111-2011)Philips Healthcare Inc.2011-08-31
Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl recall (Z-2976-2011)Philips Healthcare Inc.2011-08-10
Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a mul recall (Z-2765-2011)Philips Healthcare Inc.2011-07-08
Philips SureSigns VM Series Patient Monitors: VM4, VM6, VM 8: Model Part Numbers VM4 86306 recall (Z-2583-2011)Philips Healthcare Inc.2011-06-17
Philips SureSigns VS3 Vital Signs Monitor Models: VS3 863069, 863070, 453564041251, 453564 recall (Z-2584-2011)Philips Healthcare Inc.2011-06-17
Philips Microstream Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are recall (Z-2247-2011)Philips Healthcare Inc.2011-05-26
Philips Microstream Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS These recall (Z-2248-2011)Philips Healthcare Inc.2011-05-26
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVu recall (Z-2217-2011)Philips Healthcare Inc.2011-05-19
Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue C recall (Z-2175-2011)Philips Healthcare Inc.2011-05-10
Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F recall (Z-1609-2011)Philips Healthcare Inc.2011-03-08
BuckyDiagnost general purpose x-ray system with Optimus Generator. General Purpose Diagnos recall (Z-0905-2011)Philips Healthcare Inc.2011-03-04
Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Release recall (Z-0987-2011)Philips Healthcare Inc.2011-01-27
The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) recall (Z-0617-2011)Philips Healthcare Inc.2010-12-14
Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Softw recall (Z-0414-2011)Philips Healthcare Inc.2010-11-18
HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J / M3536MC The HeartS recall (Z-0322-2011)Philips Healthcare Inc.2010-11-08
Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals recall (Z-2625-2010)Philips Healthcare Inc.2010-09-29
Philips M8102A IntelliVue MP2 Model: 865040 Indicated for use by health care professionals recall (Z-2626-2010)Philips Healthcare Inc.2010-09-29
HeartStart MRx Defibrillator/Monitor with Q-CPR Meter option.The HeartStart MRx monitor/de recall (Z-2293-2010)Philips Healthcare Inc.2010-08-27
Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds recall (Z-2263-2010)Philips Healthcare Inc.2010-08-24
Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds recall (Z-2264-2010)Philips Healthcare Inc.2010-08-24
Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds recall (Z-2265-2010)Philips Healthcare Inc.2010-08-24
Philips M1026BT Gas Modules with manifolds recall (Z-2266-2010)Philips Healthcare Inc.2010-08-24
Philips Intellivue Patient Monitor Model MP60 (M8005A) recall (Z-2201-2010)Philips Healthcare Inc.2010-08-10
Philips Intellivue Patient Monitor Model MP70 (M8007A) recall (Z-2202-2010)Philips Healthcare Inc.2010-08-10
HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx Defibrillator Monitor, M recall (Z-1618-2010)Philips Healthcare Inc.2010-05-24
HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips recall (Z-1317-2010)Philips Healthcare Inc.2010-04-09
AC power cords manufactured by Electri-Cord with tall bridge design. Used across all Phili recall (Z-1257-2010)Philips Healthcare Inc.2010-04-08
HeartStart MRx Defibrillator/Monitor. For use for the termination of ventricular tachycard recall (Z-1258-2010)Philips Healthcare Inc.2010-04-08
HeartStart MRx- AC power module kit. For use for the termination of ventricular tachycardi recall (Z-1259-2010)Philips Healthcare Inc.2010-04-08
DeviceLink Connectivity Hardware. Supports Philips specified manufacturers' devices includ recall (Z-1260-2010)Philips Healthcare Inc.2010-04-08
Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended use of the Capnostat 5 recall (Z-1261-2010)Philips Healthcare Inc.2010-04-08
NICO2, Model 7600 Respironics/Philips Product. Intended use is cardiac output monitoring v recall (Z-1262-2010)Philips Healthcare Inc.2010-04-08
Sharn TidalGuard SP 710V, Respironics/Philips product. Intended use of the monitors is to recall (Z-1263-2010)Philips Healthcare Inc.2010-04-08
C5 LOFLO Evaluation Kit, Respironics/Philips product. Intended use of the LoFlo C5 CO2 sen recall (Z-1264-2010)Philips Healthcare Inc.2010-04-08
Evaluation Kit, LOFLO Engine, Respironics/Philips product. Intended use of the LoFlo C5 CO recall (Z-1265-2010)Philips Healthcare Inc.2010-04-08
100-120V Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring e recall (Z-1266-2010)Philips Healthcare Inc.2010-04-08
Spanish Capnogard 1265, Respironics/Philips product. Intended to be used for monitoring en recall (Z-1267-2010)Philips Healthcare Inc.2010-04-08
Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips product. Intended to be used recall (Z-1268-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips products. Intended to be used recall (Z-1269-2010)Philips Healthcare Inc.2010-04-08
Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product. Used for trending O2 a recall (Z-1270-2010)Philips Healthcare Inc.2010-04-08
French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips product. Used for trending O2 recall (Z-1271-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V TCOM-860, Respironics/Philips product. Used for trending O2 and CO2 tensi recall (Z-1272-2010)Philips Healthcare Inc.2010-04-08
Tidal wave, Model 610, Respironics/Philips product. Intended use of the monitors is to pro recall (Z-1273-2010)Philips Healthcare Inc.2010-04-08
Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide spirometri recall (Z-1274-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide spirometric recall (Z-1275-2010)Philips Healthcare Inc.2010-04-08
TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to provide recall (Z-1276-2010)Philips Healthcare Inc.2010-04-08
Japanese TidalWave SP 710, Respironics/Philips product. Intended use of the monitors is to recall (Z-1277-2010)Philips Healthcare Inc.2010-04-08
Tidal Wave Sp Model 715, Respironics/Philips product. Intended use of the monitors is to p recall (Z-1278-2010)Philips Healthcare Inc.2010-04-08
Japanese TidalWave SP 715, Respironics/Philips product. Intended use of the monitors is to recall (Z-1279-2010)Philips Healthcare Inc.2010-04-08
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