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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA Regulatory Profile

Summary

Total Recalls
162 (20 Class I)
510(k) Clearances
102
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1347-2026Class IIAzurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - AllJanuary 26, 2026
Z-1344-2026Class IIAzurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - January 26, 2026
Z-1349-2026Class IIAzurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); SoftwareJanuary 26, 2026
Z-1351-2026Class IIAzurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version NuJanuary 26, 2026
Z-1350-2026Class IIAzurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: January 26, 2026
Z-1346-2026Class IIAzurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - AJanuary 26, 2026
Z-1348-2026Class IIAzurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - AllJanuary 26, 2026
Z-1345-2026Class IIAzurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); SoftwJanuary 26, 2026
Z-1075-2026Class IIAllura Xper FD20; Model Number: 722028;December 15, 2025
Z-1076-2026Class IIAllura Xper FD20/10; Model Number: 722029;December 15, 2025
Z-1066-2026Class IIAllura Xper FD20; Model Number: 722006;December 15, 2025
Z-1070-2026Class IIAllura Xper FD20; Model Number: 722012;December 15, 2025
Z-1068-2026Class IIAllura Xper FD10; Model Number: 722010;December 15, 2025
Z-1072-2026Class IIAllura Xper FD20 OR Table; Model Number: 722023;December 15, 2025
Z-1077-2026Class IIAllura Xper FD20/20; Model Number: 722038;December 15, 2025
Z-1074-2026Class IIAllura Xper FD10/10; Model Number: 722027;December 15, 2025
Z-1069-2026Class IIAllura Xper FD10/10; Model Number: 722011;December 15, 2025
Z-1067-2026Class IIAllura Xper FD20 Biplane; Model Number: 722008;December 15, 2025
Z-1065-2026Class IIAllura Xper FD10/10; Model Number: 722005;December 15, 2025
Z-1062-2026Class IIProduct Name: Allura Xper FD10C; Model number: 722001;December 15, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
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
K242879dS Knee Coil 8ch 1.5TOctober 18, 2024
K243033dS Wrist coil 8ch 1.5TOctober 18, 2024
K242096dS FootAnkle Coil 8ch 1.5TAugust 12, 2024
K233204Philips IntelliSite Pathology Solution 5.1June 24, 2024
K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubMarch 14, 2024