Philips Medical Systems
Philips Medical Systems holds FDA 510(k) medical device clearances, first cleared 2002, most recent 2021, with 16 FDA device recalls on record.
Top product codes for Philips Medical Systems
FDA recalls by Philips Medical Systems
10 most recent of 16- Z-2651-2026 — IQon Spectral CT IQon Spectral CT Upgrades
- Z-2650-2026 — Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
- Z-2652-2026 — Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
- Z-1825-2026 — Philips Spectral CT on Rails. Model Number: 728334.
- Z-0375-2026 — Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
- Z-0377-2026 — Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
- Z-0376-2026 — Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
- Z-1055-2024 — Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
- Z-1054-2024 — Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
- Z-1088-2024 — CombiDiagnost R90 1.1 (709031)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Philips Medical Systems
1–100 of 107- K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
- K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
- K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
- K192875 — Philips Biosensor BX100
- K183387 — M3290B Patient Information Center iX
- K180017 — MX40 Release C.01
- K172226 — MX40 Release B.07
- K163584 — M3290B Philips IntelliVue Information Center iX
- K163649 — SureSigns VS3; SureSigns VS4
- K161164 — CareEvent inclusive of the CareEvent Mobile Application accessory
- K153702 — M3290B Philips IntelliVue Information Center iX
- K160951 — Philips Efficia CMS200 Central Monitoring System
- K151812 — PATIENT MONITORS VARIOUS MODELS
- K151366 — Philips CS770 IntelliSpace Critical Care and Anesthesia
- K152363 — Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
- K133659 — HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
- K142935 — CareEvent
- K143057 — M3290B Philips IntelliVue Information Center iX
- K133603 — PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
- K133961 — SURESIGNS VS3, SURESIGNS VS4
- K132524 — CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
- K131590 — INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
- K130684 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
- K132068 — PHILIPS DXL 12/16-LEAD ECG ALGORITHM
- K131032 — PHILIPS SURESIGNS CENTRAL
- K123900 — SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
- K130153 — HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
- K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
- K123492 — DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
- K113144 — PAGEWRITER TC 20, 30, 50, 70
- K110825 — PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
- K120132 — SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
- K113125 — INTELLIVUE MX40 PATIENT MONITOR
- K111693 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
- K112652 — SURESIGNS VS2+ -SURESIGNS VSI
- K110572 — MAMMODIAGNOST DR
- K110803 — SURESIGNS VSI VITAL SIGNS MONITOR
- K111114 — SURESIGNS VS2 VITAL SIGNS MONITOR
- K110287 — PHILIPS ECG LEADWIRE SET
- K102974 — INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
- K102495 — M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
- K101521 — ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
- K101067 — SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
- K100272 — INTELLIVUE CLINICAL INFORMATION PORTFOLIO
- K093177 — INTELLIBRIDGE SYSTEM
- K091176 — PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
- K090483 — SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
- K083413 — COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
- K081983 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
- K080999 — PAGEWRITER CARDIOGRAPH
- K073376 — PHILIPS ECG ALGORITHM
- K080495 — SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
- K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
- K072812 — PHILIPS HEARTSTART SMARTPADS III
- K071885 — ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
- K071564 — MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
- K070588 — PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
- K070260 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
- K063375 — HEARTSTART MRX, MODELS M3535A OR M3536A
- K063559 — ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
- K062271 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
- K062605 — PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
- K062455 — PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
- K062650 — EP NAVIGATOR SOFTWARE
- K061707 — HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
- K052961 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
- K052707 — M3046B COMPACT PORTABLE PATIENT MONITORS
- K051632 — PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
- K051134 — HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
- K052049 — PHILIPS 12-LEAD ALGORITHM
- K050742 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
- K050004 — PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304
- K040904 — PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A
- K041674 — THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
- K041401 — MODIFICATION TO M2376A DEVICELINK SYSTEM
- K033513 — EASI ECG ALGORITHM
- K033680 — M2376A PHILIPS DEVICE LINK SYSTEM
- K033444 — PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER
- K031815 — INTERA-SENSATION FAMILY
- K031187 — HEARTSTART MRX, MODEL M3535A
- K030973 — PICOSAT II SPO2 PULSE OXIMETRY MODULE
- K032103 — PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
- K032096 — PHILIPS VIEWFORUM 2003
- K030939 — PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
- K031422 — PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
- K030417 — DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
- K023871 — M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY
- K023674 — PHILIPS DRUG CALCULATOR SOFTWARE
- K023698 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
- K023749 — THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
- K020715 — PHILIPS M5066A AND M5068A
- K023440 — PHILIPS DIGITAL IMAGING OPTION RELEASE 1
- K023441 — PHILIPS MULTIDIAGNOST ELEVA
- K022920 — M2376A DEVICELINK SYSTEM
- K021778 — PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
- K020456 — EASI 12 LEAD ALGORITHM
- K021453 — HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
- K021422 — PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
- K021300 — MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
Data sourced from openFDA. This site is unofficial and independent of the FDA.