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Philips Medical Systems Nederland B.v recalls - full list & free alerts

76 official U.S. recalls involving Philips Medical Systems Nederland B.v in the last 12 months, most recently on 2026-08-19.

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Full list (76)

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Medical DevicesFDA (device) ยท 2026-08-19 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 7222
Medical DevicesFDA (device) ยท 2026-08-19 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 an
Medical DevicesFDA (device) ยท 2026-08-19 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010
Medical DevicesFDA (device) ยท 2026-08-12 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221.
Medical DevicesFDA (device) ยท 2026-08-12 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Medical DevicesFDA (device) ยท 2026-08-12 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost E
Medical DevicesFDA (device) ยท 2026-06-24 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 72
Medical DevicesFDA (device) ยท 2026-06-24 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Sof
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software k
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software k
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So
Medical DevicesFDA (device) ยท 2026-06-10 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (7222
Medical DevicesFDA (device) ยท 2026-06-03 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033
Medical DevicesFDA (device) ยท 2026-06-03 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding mode
Medical DevicesFDA (device) ยท 2026-05-27 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B
Medical DevicesFDA (device) ยท 2026-05-27 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 72
Medical DevicesFDA (device) ยท 2026-05-27 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (
Medical DevicesFDA (device) ยท 2026-05-27 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281),
Medical DevicesFDA (device) ยท 2026-05-20 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combi
Medical DevicesFDA (device) ยท 2026-04-22 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10C; System Code: 722001;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD10F; System Code: 722002;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/10; System Code: 722029;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/20; System Code: 722038;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/20 OR Table; System Code: 722039;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/15; System Code: 722058;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/15 OR Table; System Code: 722059;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 5 M12; System Code: (1)722227, (2)722231;
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Vue Motion V12. Product Number: 1017979.
Medical DevicesFDA (device) ยท 2026-04-08 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X,
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Medical DevicesFDA (device) ยท 2026-02-18 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion system; Software Version Number: R3.1;
Medical DevicesFDA (device) ยท 2026-01-28 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Product Name: Allura Xper FD10C; Model number: 722001;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10F; Model Number: 722002;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10; Model Number: 722003;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10/10; Model Number: 722005;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20; Model Number: 722006;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20 Biplane; Model Number: 722008;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10; Model Number: 722010;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10/10; Model Number: 722011;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20; Model Number: 722012;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20 Biplane; Model Number: 722013;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20 OR Table; Model Number: 722023;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10; Model Number: 722026;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10/10; Model Number: 722027;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20; Model Number: 722028;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/10; Model Number: 722029;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD20/20; Model Number: 722038;
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229.
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1
Medical DevicesFDA (device) ยท 2026-01-21 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Medical DevicesFDA (device) ยท 2025-12-03 ยท Class II
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
Medical DevicesFDA (device) ยท 2025-10-29 ยท Class II