Philips Medical Systems DMC GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 18
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0462-2026 | Class II | CombiDiagnost R90; Model Number: 709031; | October 1, 2025 |
| Z-0464-2026 | Class II | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; | October 1, 2025 |
| Z-0463-2026 | Class II | Precision CRF; Model Number: 706400; | October 1, 2025 |
| Z-0461-2026 | Class II | ProxiDiagnost N90; Model Number: 706110; | October 1, 2025 |
| Z-0465-2026 | Class II | DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 71 | October 1, 2025 |
| Z-0466-2026 | Class II | Radiography 7300 C; Model Number: 712037; | October 1, 2025 |
| Z-1329-2022 | Class II | DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system | May 19, 2021 |
| Z-1325-2022 | Class II | ProxiDiagnost N90. radiography and fluoroscopy system | May 19, 2021 |
| Z-1326-2022 | Class II | DigitalDiagnost 4 High Performance. radiography and fluoroscopy system | May 19, 2021 |
| Z-1328-2022 | Class II | DigitalDiagnost C90 High Performance. radiography and fluoroscopy system | May 19, 2021 |
| Z-1327-2022 | Class II | DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system | May 19, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233662 | Radiography 7300 C | June 13, 2024 |
| K233678 | Radiography 7000 M | February 14, 2024 |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | January 11, 2024 |
| K232910 | CombiDiagnost R90 | October 19, 2023 |
| K212186 | Philips Radiology Smart Assistant | December 13, 2021 |
| K212837 | ProxiDiagnost N90 | September 21, 2021 |
| K210692 | DigitalDiagnost | April 2, 2021 |
| K203087 | CombiDiagnost R90 | December 3, 2020 |
| K202564 | DigitalDiagnost C90 | September 30, 2020 |
| K182973 | DigitalDiagnost C90 | January 11, 2019 |
| K173433 | ProxiDiagnost N90 | February 5, 2018 |
| K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | July 7, 2017 |
| K170113 | pixium 4343RCE | February 9, 2017 |
| K163210 | Philips CombiDiagnost R90 | January 31, 2017 |
| K153318 | Philips Eleva Workspot with SkyFlow | December 22, 2015 |
| K141736 | PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST | July 25, 2014 |
| K140771 | PHILIPS ELEVA WORKSPOT | April 25, 2014 |
| K131483 | PHILIPS PIXIUM 4343RC | October 7, 2013 |