Name: FDA Enforcement Actions Against Philips Medical Systems Nederland B.V.
Creator: Argus HQ
License: https://argushq.ai/methodology

Philips Medical Systems Nederland B.V. is the Best, Netherlands manufacturing entity behind Philips's interventional cath-lab X-ray hardware -- Allura Xper, Azurion, Zenition, and related platforms -- and is tracked separately in the FDA record from its US sister entity, Philips North America. Argus HQ tracks 199 device recalls against this entity across 42 distinct FDA report dates from April 2023 through June 2026, with 20 rated Class I (most serious). The recurring recall themes visible in the reason field are software/imaging-loss issues, FlexArm/table mechanical faults, and X-ray tube cooling component failures -- the tables below compute the exact severity mix, month-by-month velocity, and reason-pattern breakdown from those records, each linked to its FDA.gov source.

FDA action counts (Argus HQ database)

Total tracked FDA actions	199
Recalls	199
Warning letters	0
Form 483 inspection citations	0
Most recent tracked action	June 24, 2026
Most severe rating on file	critical

Recall severity breakdown

Computed from all 199 tracked recalls. FDA classifies each recall Class I (most serious), II, or III on the underlying record; Argus HQ maps that to critical/high/medium/low severity buckets.

high	179 (89.9%)
critical	20 (10.1%)

Recall velocity by month

Months with at least one tracked recall for Philips Medical Systems Nederland B.V., oldest to most recent. Gaps indicate months with zero tracked recalls, not missing data.

Month	Recalls
2023-04	2
2023-06	1
2023-08	2
2023-09	5
2023-12	2
2024-02	11
2024-06	4
2024-08	2
2024-09	5
2024-11	2
2024-12	1
2025-02	39
2025-03	2
2025-04	1
2025-05	15
2025-06	1
2025-07	1
2025-08	1
2025-09	4
2025-10	29
2025-12	1
2026-01	19
2026-02	8
2026-04	24
2026-05	5
2026-06	12

Recurring recall-reason patterns

Argus HQ keyword-matched the free-text “reason for recall” field on each tracked record into categories below. FDA does not publish a structured reason code for device recalls, so this is Argus HQ’s own pattern analysis, not an official FDA classification — records that don’t match a listed keyword fall into “Other.”

Other / not pattern-matched	155 recalls
Battery	28 recalls
Software	14 recalls
Sterility	2 recalls

Full recall history (199)

Most recent first. Every row links to its Argus HQ record and FDA.gov source.

Date	Severity	Title
2026-06-24	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032…
2026-06-24	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.…
2026-06-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2…
2026-06-03	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063,…
2026-06-03	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003…
2026-05-27	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion systems not configured with an optional auxiliary pan handle. In…
2026-05-27	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72200…
2026-05-27	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Integris-Allura system; System Code Description (Model Numbers): Integris CV Ces…
2026-05-27	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063),…
2026-05-20	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221,…
2026-04-22	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic…
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Vue Motion V12. Product Number: 1017979.
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10C; System Code: 722001;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M12; System Code: (1)722227, (2)722231;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20 OR Table; System Code: 722039;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/15; System Code: 722058;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only…
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD10F; System Code: 722002;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20; System Code: 722038;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only…
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/15 OR Table; System Code: 722059;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/10; System Code: 722029;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
2026-04-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only);…
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Softwar…
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software…
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(…
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7222…
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software…
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Softwa…
2026-02-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Num…
2026-01-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion system; Software Version Number: R3.1;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20; Model Number: 722028;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/10; Model Number: 722029;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20; Model Number: 722038;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Product Name: Allura Xper FD10C; Model number: 722001;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion Systems R3.0. Includes the following label descriptions and corr…
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the…
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20; Model Number: 722012;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10/10; Model Number: 722011;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 Biplane; Model Number: 722008;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10F; Model Number: 722002;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 OR Table; Model Number: 722023;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10/10; Model Number: 722005;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10; Model Number: 722010;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 Biplane; Model Number: 722013;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10; Model Number: 722026;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10/10; Model Number: 722027;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20; Model Number: 722006;
2026-01-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10; Model Number: 722003;
2025-12-03	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number:…
2025-10-29	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray sy…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005,…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035;…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associate…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638,…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associate…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K10…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Asso…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associ…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K1306…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 51…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K1020…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K1306…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K1306…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638,…
2025-10-08	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K1020…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associat…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 51…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Asso…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842,…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k)…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K…
2025-10-01	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 51…
2025-09-17	high	Philips Medical Systems Nederland B.V. — Class II recall: IntelliSpace Cardiovascular, Software 8.0.0.4.
2025-09-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled a…
2025-09-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x…
2025-09-10	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x).…
2025-08-06	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10,…
2025-07-30	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M20. Fluoroscopic X-Ray System.
2025-06-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 72206…
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 3.0T Quasar Dual, Model Number: 781150;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera CV, Model Number: 781107;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: SmartPath to dStream for 3.0T, Model Number: 782145;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.0T Omni/Stellar, Model Number: 781102;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.5T Omni/Stellar, Model Number: 781104;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.5T, Model Numbers: 781195 and 781295;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Enterprise 1.5T, Model Number: 781145;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: SmartPath to dStream for 1.5T, Model Number: 782146;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.5T Master/Nova, Model Number: 781106;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 0.5T Standard, Model Number: 781101;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.5T R11, Model Number: 781170;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.5T Power/Pulsar, Model Number: 781105;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
2025-05-21	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Intera 1.0T Power/Pulsar, Model Number: 781103;
2025-05-14	high	Philips Medical Systems Nederland B.V. — Class II recall: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 8…
2025-04-30	high	Philips Medical Systems Nederland B.V. — Class II recall: Zenition 70. The device is to be used in health care facilities both inside and…
2025-03-19	high	Philips Medical Systems Nederland B.V. — Class II recall: Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
2025-03-12	high	Philips Medical Systems Nederland B.V. — Class II recall: Philips IntelliSpace Cardiovascular software, Model 830089.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (…
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (O…
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD10C; Catalog number: 722001
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD20/20; Catalog numbers: 722038
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD20/15; Catalog numbers: 722058
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD20/10; Catalog numbers: 722029
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura CV20; Catalog numbers: 722031
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
2025-02-26	critical	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class I recall: Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 M12 System Code: (1) 722227 (2) 722231
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura CV20 System Code: 722031
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: AlluraXperFD20/15 System Code: (1) 722058
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: AlluraXperFD20/10 System Code: (1) 722029
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10C System Code: (1) 722001
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 M12 System Code: (1) 722063 (2) 722221
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD20/20 System Code: (1) 722038
2025-02-12	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282…
2024-12-18	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura…
2024-11-20	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Zenition 50, Model Number: 718096
2024-11-20	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Zenition 70, Model Number: 718133
2024-09-25	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 7220…
2024-09-25	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Pow…
2024-09-25	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20…
2024-09-25	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost…
2024-09-11	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional…
2024-08-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic…
2024-08-14	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion Interventional Fluoroscopic X-ray System with Software Version N…
2024-06-05	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722…
2024-06-05	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software…
2024-06-05	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Num…
2024-06-05	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, int…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, int…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, in…
2024-02-28	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the…
2024-02-07	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (S…
2024-02-07	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion system, Interventional fluoroscopic x-ray system. System Prod…
2024-02-07	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (S…
2023-12-27	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper…
2023-12-27	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M…
2023-09-20	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and Multi…
2023-09-13	high	Philips Medical Systems Nederland B.V. — Class II recall: Allura Xper series
2023-09-13	high	Philips Medical Systems Nederland B.V. — Class II recall: Azurion
2023-09-13	high	Philips Medical Systems Nederland B.V. — Class II recall: MultiDiagnost-Eleva
2023-09-06	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventi…
2023-08-09	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion 7 M20. X-ray Image guided Therapy System.
2023-08-09	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Allura Xper FD10 and FD20. X-ray Imaging System.
2023-06-07	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 a…
2023-04-26	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
2023-04-26	high	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: 2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

Coverage

No independent news coverage was found for Philips Medical Systems Nederland B.V.’s FDA recall history at the time this page was published — its enforcement record is small enough that it hasn’t drawn trade-press attention. This page is the most complete public record available.

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Full FDA history for Philips Medical Systems Nederland B.V.

Other enforcement deep dives

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Jun 24, 2026

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Philips Medical Systems Nederland B.V.: FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/enforcement/philips-medical-systems-nederland-b-v

MLA

"Philips Medical Systems Nederland B.V.: FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/enforcement/philips-medical-systems-nederland-b-v.

Chicago

Argus HQ Research. "Philips Medical Systems Nederland B.V.: FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/enforcement/philips-medical-systems-nederland-b-v.

BibTeX

@misc{argushq_argushq_ai_enforcement_philips_medical_systems_nederland_b_v_2026,
  title = {Philips Medical Systems Nederland B.V.: FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/enforcement/philips-medical-systems-nederland-b-v},
  note = {Accessed: July 24, 2026}
}

Source: FDA.gov (aggregated device recalls) ↗