Philips Medical Systems Nederland B.V.

FDA Regulatory Profile

Philips Medical Systems Nederland B.V. appears in FDA public data with 209 recalls — including 20 Class I (most serious) —, 107 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2932-2026, Class II) was initiated on July 16, 2026. Its most recent 510(k) clearance was granted on August 7, 2026.

Summary

Total Recalls
209 (20 Class I)
510(k) Clearances
107
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2932-2026Class IIPhilips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236,July 16, 2026
Z-2931-2026Class IIPhilips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722July 16, 2026
Z-2928-2026Class IIAllura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. InJune 29, 2026
Z-2891-2026Class IIPhilips Allura under the following System Descriptions and corresponding model numbers: 1. Allura June 17, 2026
Z-2892-2026Class IIPhilips Azurion under the following System Descriptions and corresponding model numbers: 1. AzurioJune 17, 2026
Z-2893-2026Class IIPhilips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional FluoroscopicJune 17, 2026
Z-2412-2026Class IIPhilips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # May 18, 2026
Z-2411-2026Class IIPhilips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost ElMay 18, 2026
Z-2259-2026Class IIAllura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), AApril 30, 2026
Z-2258-2026Class IIAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 MApril 30, 2026
Z-2229-2026Class IIIntegris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-NApril 28, 2026
Z-2228-2026Class IIAllura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10April 28, 2026
Z-2227-2026Class IIAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (7220April 28, 2026
Z-2225-2026Class IIPhilips Azurion systems not configured with an optional auxiliary pan handle. Includes the below proApril 28, 2026
Z-2170-2026Class IIPhilips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 MMarch 31, 2026
Z-1805-2026Class IIPhilips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (InterventMarch 19, 2026
Z-1692-2026Class IIVue Motion V12. Product Number: 1017979.March 5, 2026
Z-1664-2026Class IIALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;March 3, 2026
Z-1676-2026Class IIAzurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;March 3, 2026
Z-1677-2026Class IIAzurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;March 3, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K254205Zenition 30August 7, 2026
K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS July 30, 2026
K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CHJuly 24, 2026
K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)May 27, 2026
K253614EchoNavigator R5.0March 17, 2026
K260169AV Cardiac CTMarch 5, 2026
K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 77February 23, 2026
K253735AV VascularJanuary 22, 2026
K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TJanuary 14, 2026
K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubOctober 24, 2025
K251215Philips IntelliSpace CardiovascularOctober 2, 2025
K250181AV ViewerJuly 15, 2025
K251808Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; InJuly 11, 2025
K250648Philips iCT CT systemJune 27, 2025
K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemJune 4, 2025
K242001Philips VSC-MEDlibApril 4, 2025
K243871Philips IntelliSite Pathology Solution 5.1March 6, 2025
K242848Philips IntelliSite Pathology Solution 5.1December 10, 2024
K241871Philips IntelliSite Pathology SolutionDecember 2, 2024
K242512ROCC ConsoleOctober 24, 2024