Philips Medical Systems Nederlands
FDA Regulatory Profile
Philips Medical Systems Nederlands appears in FDA public data with 79 recalls, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1240-2019, Class II) was initiated on March 25, 2019. Its most recent 510(k) clearance was granted on May 22, 2024.
Summary
- Total Recalls
- 79
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1240-2019 | Class II | Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), | March 25, 2019 |
| Z-1141-2019 | Class II | Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD1 | February 19, 2019 |
| Z-1140-2019 | Class II | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 70803 | February 19, 2019 |
| Z-0888-2019 | Class II | Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0914-2019 | Class II | Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0919-2019 | Class II | Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0918-2019 | Class II | Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0921-2019 | Class II | Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0896-2019 | Class II | Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0915-2019 | Class II | Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0898-2019 | Class II | Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0912-2019 | Class II | Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0895-2019 | Class II | Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0916-2019 | Class II | Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0927-2019 | Class II | Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0901-2019 | Class II | Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0903-2019 | Class II | SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging Syst | December 21, 2018 |
| Z-0890-2019 | Class II | Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0911-2019 | Class II | Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
| Z-0926-2019 | Class II | MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System | December 21, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240224 | Zenition 90 | May 22, 2024 |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | December 23, 2022 |
| K201743 | ClarifEye R1.0, ClarifEye Needle | February 23, 2021 |
| K181311 | Philips Hemodynamic Application R1.0 | September 7, 2018 |
| K181966 | SmartPerfusion | August 17, 2018 |
| K162025 | IntelliSpace Portal Platform | October 18, 2016 |
| K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 | March 22, 2016 |
| K143128 | mDIXON XD | March 20, 2015 |