PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Regulatory Profile
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. appears in FDA public data with 203 recalls — including 20 Class I (most serious) —, 104 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2411-2026, Class II) was initiated on May 18, 2026. Its most recent 510(k) clearance was granted on May 27, 2026.
Summary
- Total Recalls
- 203 (20 Class I)
- 510(k) Clearances
- 104
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2411-2026 | Class II | Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost El | May 18, 2026 |
| Z-2412-2026 | Class II | Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # | May 18, 2026 |
| Z-2258-2026 | Class II | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M | April 30, 2026 |
| Z-2259-2026 | Class II | Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), A | April 30, 2026 |
| Z-2225-2026 | Class II | Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below pro | April 28, 2026 |
| Z-2229-2026 | Class II | Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-N | April 28, 2026 |
| Z-2228-2026 | Class II | Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10 | April 28, 2026 |
| Z-2227-2026 | Class II | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (7220 | April 28, 2026 |
| Z-2170-2026 | Class II | Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M | March 31, 2026 |
| Z-1805-2026 | Class II | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Intervent | March 19, 2026 |
| Z-1692-2026 | Class II | Vue Motion V12. Product Number: 1017979. | March 5, 2026 |
| Z-1670-2026 | Class II | Allura Xper FD20/20 OR Table; System Code: 722039; | March 3, 2026 |
| Z-1674-2026 | Class II | Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); | March 3, 2026 |
| Z-1676-2026 | Class II | Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | March 3, 2026 |
| Z-1677-2026 | Class II | Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; | March 3, 2026 |
| Z-1680-2026 | Class II | Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); | March 3, 2026 |
| Z-1672-2026 | Class II | Allura Xper FD20/15 OR Table; System Code: 722059; | March 3, 2026 |
| Z-1675-2026 | Class II | Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; | March 3, 2026 |
| Z-1663-2026 | Class II | ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; | March 3, 2026 |
| Z-1666-2026 | Class II | ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; | March 3, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260207 | Multimodality Simulation Workspace (MM Sim) (v1.0.0) | May 27, 2026 |
| K253614 | EchoNavigator R5.0 | March 17, 2026 |
| K260169 | AV Cardiac CT | March 5, 2026 |
| K253648 | Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 77 | February 23, 2026 |
| K253735 | AV Vascular | January 22, 2026 |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T | January 14, 2026 |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | October 24, 2025 |
| K251215 | Philips IntelliSpace Cardiovascular | October 2, 2025 |
| K250181 | AV Viewer | July 15, 2025 |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; In | July 11, 2025 |
| K250648 | Philips iCT CT system | June 27, 2025 |
| K251397 | Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System | June 4, 2025 |
| K242001 | Philips VSC-MEDlib | April 4, 2025 |
| K243871 | Philips IntelliSite Pathology Solution 5.1 | March 6, 2025 |
| K242848 | Philips IntelliSite Pathology Solution 5.1 | December 10, 2024 |
| K241871 | Philips IntelliSite Pathology Solution | December 2, 2024 |
| K242512 | ROCC Console | October 24, 2024 |
| K242879 | dS Knee Coil 8ch 1.5T | October 18, 2024 |
| K243033 | dS Wrist coil 8ch 1.5T | October 18, 2024 |
| K242096 | dS FootAnkle Coil 8ch 1.5T | August 12, 2024 |