Company ยท US
Philips Medical Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2026. Name variants (Inc, Corp, punctuation) are merged.
221510(k) clearances (2 in 12 months)
180recalls (5 in 12 months)
176recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 64 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 39 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 31 |
| KPS | System, Tomography, Computed, Emission | 28 |
| JAK | System, X-Ray, Tomography, Computed | 25 |
| OWB | Interventional Fluoroscopic X-Ray System | 20 |
| LLZ | System, Image Processing, Radiological | 19 |
| DQA | Oximeter | 13 |
| IYE | Accelerator, Linear, Medical | 12 |
| DPS | Electrocardiograph | 11 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 10 |
| IZI | System, X-Ray, Angiographic | 10 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 10 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 7 |
| KPR | System, X-Ray, Stationary | 7 |
| DSI | Detector And Alarm, Arrhythmia | 6 |
| MSX | System, Network And Communication, Physiological Monitors | 6 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 4 |
| DXJ | Display, Cathode-Ray Tube, Medical | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2026 | K253670 | SmartCT (R3.0 (L10)) Philips Medical Systems B.V., NL | OWB |
| Jan 16, 2026 | K254186 | Azurion R3.1 Philips Medical Systems B.V., NL | OWB |
| Oct 24, 2025 | K251827 | Azurion R3.1 Philips Medical Systems B.V., NL | OWB |
| Sep 24, 2021 | K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System Philips Medical Systems | IYN |
| Sep 8, 2021 | K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System Philips Medical Systems | IYN |
| Jun 30, 2021 | K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph Philips Medical Systems, CN | DPS |
| Sep 29, 2020 | K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph Philips Medical Systems, CN | DPS |
| Apr 16, 2020 | K192875 | Philips Biosensor BX100 Philips Medical Systems | DRG |
| Aug 6, 2019 | K183387 | M3290B Patient Information Center iX Philips Medical Systems | MHX |
| Jul 24, 2018 | K180017 | MX40 Release C.01 Philips Medical Systems | MHX |
| Nov 9, 2017 | K172226 | MX40 Release B.07 Philips Medical Systems | MHX |
| Jul 7, 2017 | K163584 | M3290B Philips IntelliVue Information Center iX Philips Medical Systems | MHX |
| Mar 31, 2017 | K163649 | SureSigns VS3; SureSigns VS4 Philips Medical Systems | DSJ |
| Jun 24, 2016 | K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory Philips Medical Systems | MSX |
| Jun 13, 2016 | K153702 | M3290B Philips IntelliVue Information Center iX Philips Medical Systems | MHX |
| May 5, 2016 | K160951 | Philips Efficia CMS200 Central Monitoring System Philips Medical Systems | MHX |
| Jan 26, 2016 | K151812 | PATIENT MONITORS VARIOUS MODELS Philips Medical Systems | MHX |
| Oct 30, 2015 | K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia Philips Medical Systems | DXJ |
| Oct 27, 2015 | K152363 | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Philips Medical Systems | DXQ |
| Jan 23, 2015 | K133659 | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING Philips Medical Systems | MKJ |
| Jan 15, 2015 | K142935 | CareEvent Philips Medical Systems | MSX |
| Dec 3, 2014 | K143057 | M3290B Philips IntelliVue Information Center iX Philips Medical Systems | MSX |
| Sep 25, 2014 | K133603 | PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION Philips Medical Systems | JAK |
| Jun 26, 2014 | K133961 | SURESIGNS VS3, SURESIGNS VS4 Philips Medical Systems | DSJ |
| Jun 13, 2014 | K132524 | CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION Philips Medical Systems | JAK |
| Oct 23, 2013 | K131590 | INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE Philips Medical Systems | FPD |
| Oct 18, 2013 | K130684 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems | MKJ |
| Sep 26, 2013 | K132068 | PHILIPS DXL 12/16-LEAD ECG ALGORITHM Philips Medical Systems | DPS |
| Aug 12, 2013 | K131032 | PHILIPS SURESIGNS CENTRAL Philips Medical Systems | MHX |
| Apr 18, 2013 | K123900 | SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 Philips Medical Systems | MHX |
| Mar 12, 2013 | K130153 | HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST Philips Medical Systems | MKJ |
| Mar 6, 2013 | K120815 | INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE Philips Medical Systems | FPD |
| Dec 13, 2012 | K123492 | DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) Philips Medical Systems | MOS |
| Apr 3, 2012 | K113144 | PAGEWRITER TC 20, 30, 50, 70 Philips Medical Systems | DPS |
| Feb 16, 2012 | K110825 | PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES Philips Medical Systems | MKJ |
| Feb 14, 2012 | K120132 | SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR Philips Medical Systems | DXN |
| Nov 17, 2011 | K113125 | INTELLIVUE MX40 PATIENT MONITOR Philips Medical Systems | DSI |
| Oct 28, 2011 | K111693 | PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR Philips Medical Systems | MKJ |
| Oct 11, 2011 | K112652 | SURESIGNS VS2+ -SURESIGNS VSI Philips Medical Systems | DXN |
| Sep 23, 2011 | K110572 | MAMMODIAGNOST DR Philips Medical Systems | MUE |
| May 20, 2011 | K111114 | SURESIGNS VS2 VITAL SIGNS MONITOR Philips Medical Systems | DXN |
| May 20, 2011 | K110803 | SURESIGNS VSI VITAL SIGNS MONITOR Philips Medical Systems | DXN |
| Feb 15, 2011 | K110287 | PHILIPS ECG LEADWIRE SET Philips Medical Systems | DSA |
| Jan 4, 2011 | K102974 | INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 Philips Medical Systems | MSX |
| Sep 30, 2010 | K102495 | M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 Philips Medical Systems | MHX |
| Jul 29, 2010 | K101521 | ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O Philips Medical Systems | MHX |
| May 7, 2010 | K101067 | SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 Philips Medical Systems | MHX |
| Apr 14, 2010 | K100272 | INTELLIVUE CLINICAL INFORMATION PORTFOLIO Philips Medical Systems | DXJ |
| Jan 8, 2010 | K093355 | PCR ELEVA 1.2 Philips Medical Systems, Inc. | LLZ |
| Dec 18, 2009 | K093177 | INTELLIBRIDGE SYSTEM Philips Medical Systems | MWI |
Newest 50 of 221.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | PHILIPS MEDICAL SYSTEMS Spectral CT and Spectral CT 7500 RT;
Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.);
Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 ( Open, Classified |
JAK | K244008 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS Ingenuity CT
CT5000 Ingenuity Plus
CT5000 Ingenuity Pro
CT5000 Ingenuity Premium
Ingenuity CT Upgrades
Ingenuity CT China
Ingenuity Core 128 Elite Brazil Open, Classified |
JAK | K160743 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS IQon Spectral CT
IQon Spectral CT Upgrades Open, Classified |
JAK | K193454 |
| Jul 27, 2026 | PHILIPS MEDICAL SYSTEMS Brilliance iCT
Brilliance iCT Upgrades
Brilliance iCT SP
Brilliance CT 64 Channel
CT6000
Brilliance 64 Upgrades Open, Classified |
JAK | K250648 |
| Apr 16, 2026 | PHILIPS MEDICAL SYSTEMS Philips Spectral CT on Rails. Model Number: 728334. Open, Classified |
JAK | K212875 |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: Incisive CT for Brazil SKD;
Product Code (REF): 728146;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | K180015 K212441 +1 |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: CT 5300;
Product Code (REF): 728285;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | K180015 K212441 +1 |
| Oct 27, 2025 | PHILIPS MEDICAL SYSTEMS Model: Incisive CT;
Product Code (REF): (1) 728143, (2) 728144;
Software Versions: 5.1.0.X & 5.1.1.X; Open, Classified |
JAK | K180015 K212441 +1 |
| Feb 14, 2024 | PHILIPS MEDICAL SYSTEMS CombiDiagnost R90 1.1 (709031) Open, Classified |
JAA | K203087 |
| Feb 14, 2024 | PHILIPS MEDICAL SYSTEMS CombiDiagnost R90 1.0 (709030) Open, Classified |
JAA | K163210 |
| Feb 8, 2024 | PHILIPS MEDICAL SYSTEMS Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340. Open, Classified |
JAK | K203020 |
| Feb 8, 2024 | PHILIPS MEDICAL SYSTEMS Spectral CT on Rails: Software Version 5.1.0.X, model 728334. Open, Classified |
JAK | K212875 |
| Aug 24, 2016 | Philips Medical Systems Ingenuity CT Model Number 728326
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at Terminated |
JAK | K033326 |
| Aug 24, 2016 | Philips Medical Systems Ingenuity Core 128 Model Number 728323
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data ta Terminated |
JAK | K033326 |
| Aug 24, 2016 | Philips Medical Systems Ingenuity Core Model Number 728321
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken a Terminated |
JAK | K033326 |
| Aug 24, 2016 | Philips Medical Systems Brilliance 64 CT Model Number 728231
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data take Terminated |
JAK | K033326 |
| Feb 2, 2016 | Philips Medical Systems DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 Terminated |
IYE | K130992 |
| Dec 4, 2015 | Philips Medical Systems, Inc. Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue:
866023 IntelliVue Info Center iX
866024 PIIC iX Upgrade
866117 PIIC Classic Upgrade
The intended us Terminated |
MHX | K102495 |
| Nov 23, 2015 | Philips Medical Systems, Inc. Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. Terminated |
LNH | K063559 K110151 |
| Nov 10, 2015 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillator
Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibri Terminated |
MKJ | K031187 K040404 +3 |
| Nov 5, 2015 | Philips Medical Systems, Inc. HeartStart MRx monitor/defibrillator
Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Product Usage:
The HeartStart MRx is for use for the termination of ventricular Terminated |
MKJ | K031187 K040404 +4 |
| Nov 3, 2015 | Philips Medical Systems, Inc. Philips HeartStart MRx Monitor/Defibrillators
Models: M3535A and M3536A Terminated |
MKJ | K031187 K040404 +4 |
| May 21, 2015 | Philips Medical Systems, Inc. Pinnacle3 Software Version 10.0, Model 459800200841.
Product Usage:
The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to constru Terminated |
MUJ | K041577 |
| May 19, 2015 | Philips Medical Systems, Inc. Philips Healthcare DuraDiagnost X- Ray Terminated |
KPR | K141381 |
| May 19, 2015 | Philips Medical Systems, Inc. Philips Healthcare DigitalDiagnost System X-Ray Terminated |
MQB | K141736 |
| Mar 20, 2015 | Philips Medical Systems, Inc. Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products Terminated |
LNH | K052078 |
| Mar 6, 2015 | Philips Medical Systems, Inc. Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic
Models: 712210, 712211 Terminated |
KPR | K141381 |
| Mar 2, 2015 | Philips Medical Systems, Inc. Philips Medical System Allura Xper X-Ray Angiographic Terminated |
IZI | K102005 |
| Feb 26, 2015 | Philips Medical Systems, Inc. Philips Multi Diagnost Eleva with FlatDetector Terminated |
IZI | K050151 |
| Feb 26, 2015 | Philips Medical Systems, Inc. Philips Multi Diagnost Eleva II Terminated |
IZI | K023441 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper vascular systems R7.6
Model : 722134
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper cardio systems R7.6
Model : 722133
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper vascular system
Model : 722124
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, in Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Xper cardio systems
Model : 722123
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, inte Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS H5000F/Allura 9F
Model : 722017
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS vascular System
Model : 722122
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare INTEGRIS cardio system
Model : 722121
Product Usage:
The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, i Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Allure BiPlane Series:
Model
722013 Allura Xper FD20 BIPLANE R7.6
722013 Allura Xper FD20 BIPLANE R7.7
722013 Allura Xper FD20 BIPLANE R7.8
722013 Allura Xper FD20 BIPLA Terminated |
OWB | K033737 K041949 +2 |
| Feb 3, 2015 | Philips Medical Systems, Inc. Philips Healthcare Allura Xper Series:
Allura Xper FD10
Allura Xper FD10/10
Allura Xper FD20
Allura Xper FD21
Allura Xper FD22
Allura Xper FD23
Allura Xper FD24
Allura Xper FD25
Product Usage:
The A Terminated |
OWB | K033737 K041949 +2 |
| Jan 16, 2015 | Philips Medical Systems, Inc. Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous.
The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults Terminated |
LKD | K110474 |
| Jan 13, 2015 | Philips Medical Systems, Inc. HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6
Product Usage: The HeartStart MRx is for use for the termination of v Terminated |
MKJ | K031187 K040404 +4 |
| Dec 16, 2014 | Philips Medical Systems, Inc. Gel-E Donut : 92025-A (Extra Small), 92025-B (Small),
92025-C (Medium) and Squishon 2 91033-2.
The products are intended to support and cradle a baby's head and/or body. Terminated |
FMP | None listed |
| Dec 16, 2014 | Philips Medical Systems, Inc. Philips Brilliance iCT Computed Tomography X-Ray System
Product Usage:
The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body Terminated |
JAK | K060937 |
| Dec 16, 2014 | Philips Medical Systems, Inc. Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric p Terminated |
IZL | K111725 |
| Dec 12, 2014 | Philips Medical Systems, Inc. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. Terminated |
KPS | K080927 |
| Nov 7, 2014 | Philips Medical Systems, Inc. Philips Medical Systems Allura Xper FD20C with software version R8.2.O
System Code: 722035.
The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and n Terminated |
OWB | K033737 |
| Nov 7, 2014 | Philips Medical Systems, Inc. Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028.
The Allura Xper FD series are intended for use on human patients to perform: Vascula Terminated |
OWB | K033737 |
| Oct 21, 2014 | Philips Medical Systems, Inc. Philips Avalon Monitors with software revision J.30.58:
Model Product
FM20 M2702A ;
FM30 M2703A ;
FM50 M2705A
Intended for: " Monitoring the physiological parameters of pregnant women " Non-inv Terminated |
HGM | K111083 |
| Oct 21, 2014 | Philips Medical Systems, Inc. Philips IntelliVue Monitors with software revisions J.21.03, J.21.19.
Model Product
MP5 M8105A;
MP5SC M8105AS;
MP5T M8105AT;
MP5 Upgrade M8105AU ;
MP5SC Upgrade 866327
The monitors are intend Terminated |
MHX | K122439 K131913 |
| Oct 9, 2014 | Philips Medical Systems, Inc. Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Terminated |
OWB | K002016 |
Newest 50 of 180.