Philips Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 77 (1 Class I)
- 510(k) Clearances
- 220
- Inspections
- 1
- Compliance Actions
- 0
Known Names
philips medical systems, philips medical systems (cleveland), philips medical systems nederland, philips medical systems technologies, philips medical systems dmc
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0377-2026 | Class II | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1. | September 25, 2025 |
| Z-0375-2026 | Class II | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1 | September 25, 2025 |
| Z-0376-2026 | Class II | Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X; | September 25, 2025 |
| Z-1055-2024 | Class II | Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5. | December 13, 2023 |
| Z-1054-2024 | Class II | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | December 13, 2023 |
| Z-1087-2024 | Class II | CombiDiagnost R90 1.0 (709030) | February 11, 2022 |
| Z-1088-2024 | Class II | CombiDiagnost R90 1.1 (709031) | February 11, 2022 |
| Z-0012-2017 | Class II | Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to pr | August 24, 2016 |
| Z-0010-2017 | Class II | Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to pr | August 24, 2016 |
| Z-0009-2017 | Class II | Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended t | August 24, 2016 |
| Z-0011-2017 | Class II | Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended | August 24, 2016 |
| Z-0745-2016 | Class II | DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning S | January 8, 2016 |
| Z-1643-2015 | Class II | Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software | April 23, 2015 |
| Z-1555-2015 | Class II | Philips Healthcare DuraDiagnost X- Ray | February 9, 2015 |
| Z-1554-2015 | Class II | Philips Healthcare DigitalDiagnost System X-Ray | February 9, 2015 |
| Z-0350-2016 | Class II | Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper se | February 3, 2015 |
| Z-0347-2016 | Class II | Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 | February 3, 2015 |
| Z-0346-2016 | Class II | Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 All | February 3, 2015 |
| Z-0354-2016 | Class II | Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper se | February 3, 2015 |
| Z-0353-2016 | Class II | Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper seri | February 3, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K254186 | Azurion R3.1 | January 16, 2026 |
| K251827 | Azurion R3.1 | October 24, 2025 |
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | September 24, 2021 |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | September 8, 2021 |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Write | June 30, 2021 |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC | September 29, 2020 |
| K192875 | Philips Biosensor BX100 | April 16, 2020 |
| K183387 | M3290B Patient Information Center iX | August 6, 2019 |
| K180017 | MX40 Release C.01 | July 24, 2018 |
| K172226 | MX40 Release B.07 | November 9, 2017 |
| K163584 | M3290B Philips IntelliVue Information Center iX | July 7, 2017 |
| K163649 | SureSigns VS3; SureSigns VS4 | March 31, 2017 |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | June 24, 2016 |
| K153702 | M3290B Philips IntelliVue Information Center iX | June 13, 2016 |
| K160951 | Philips Efficia CMS200 Central Monitoring System | May 5, 2016 |
| K151812 | PATIENT MONITORS VARIOUS MODELS | January 26, 2016 |
| K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | October 30, 2015 |
| K152363 | Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Car | October 27, 2015 |
| K133659 | HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING | January 23, 2015 |
| K142935 | CareEvent | January 15, 2015 |