PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: FDA recalls

FDA enforcement reports name PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. as the recalling firm in 59 events. The events have 209 product records. The recalls started from 2021 to 2026. All the events are device recalls.

See the 59 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

59 events, newest first.

FDA enforcement events of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Initiated	Product (first record)	Type	Class	Records	Status
16 Jul 2026	Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280, 722281, and 722282* (These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10 (*This software version is distributed…	Device	Class II	1	Ongoing
16 Jul 2026	Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system	Device	Class II	1	Ongoing
29 Jun 2026	Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.	Device	Class II	1	Ongoing
17 Jun 2026	Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura…	Device	Class II	3	Ongoing
18 May 2026	Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector.	Device	Class II	2	Ongoing
30 Apr 2026	Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).	Device	Class II	2	Ongoing
28 Apr 2026	Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4.…	Device	Class II	1	Ongoing
28 Apr 2026	Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).	Device	Class II	3	Ongoing
31 Mar 2026	Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12…	Device	Class II	1	Ongoing
19 Mar 2026	Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.	Device	Class II	1	Ongoing
5 Mar 2026	Vue Motion V12. Product Number: 1017979.	Device	Class II	1	Ongoing
3 Mar 2026	Allura Xper FD10C; System Code: 722001;	Device	Class II	22	Ongoing
26 Jan 2026	Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X	Device	Class II	8	Ongoing
15 Dec 2025	Product Name: Allura Xper FD10C; Model number: 722001;	Device	Class II	16	Ongoing
12 Dec 2025	Philips Azurion system; Software Version Number: R3.1;	Device	Class II	1	Ongoing
12 Dec 2025	Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers:…	Device	Class II	1	Ongoing
8 Dec 2025	Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20.…	Device	Class II	1	Ongoing
2 Oct 2025	Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;	Device	Class II	1	Ongoing
29 Sep 2025	Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system	Device	Class II	1	Ongoing
3 Sep 2025	Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;	Device	Class II	15	Ongoing
3 Sep 2025	Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;	Device	Class II	13	Ongoing
8 Aug 2025	IntelliSpace Cardiovascular, Software 8.0.0.4.	Device	Class II	1	Ongoing
1 Aug 2025	Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura…	Device	Class II	1	Ongoing
1 Aug 2025	Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12,…	Device	Class II	2	Ongoing
30 Jun 2025	Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table,…	Device	Class II	1	Ongoing
4 Jun 2025	Azurion 7 M20. Fluoroscopic X-Ray System.	Device	Class II	1	Ongoing
28 May 2025	Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;	Device	Class II	1	Ongoing
7 Apr 2025	IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.	Device	Class II	1	Ongoing
24 Mar 2025	Enterprise 1.5T, Model Number: 781145;	Device	Class II	14	Ongoing
28 Feb 2025	Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;	Device	Class II	1	Ongoing
13 Jan 2025	Allura CV20 System Code: 722031	Device	Class II	19	Ongoing
13 Jan 2025	Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,	Device	Class I	20	Ongoing
11 Nov 2024	Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper…	Device	Class II	1	Ongoing
7 Oct 2024	Philips Zenition 50, Model Number: 718096	Device	Class II	2	Ongoing
22 Aug 2024	System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azurion 3 M15 722221 Azurion 3 M12 722079…	Device	Class II	4	Ongoing
8 Aug 2024	Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013	Device	Class II	1	Ongoing
6 Aug 2024	Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224	Device	Class II	1	Ongoing
15 Jul 2024	Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model…	Device	Class II	1	Ongoing
16 May 2024	Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.	Device	Class II	3	Ongoing
2 May 2024	Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.	Device	Class II	1	Ongoing
4 Apr 2024	Philips IntelliSpace Cardiovascular software, Model 830089.	Device	Class II	1	Ongoing
6 Feb 2024	Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280	Device	Class II	3	Ongoing
2 Jan 2024	Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028;…	Device	Class II	2	Ongoing
2 Jan 2024	Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper…	Device	Class II	2	Ongoing
2 Jan 2024	Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006…	Device	Class II	1	Ongoing
12 Dec 2023	Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion…	Device	Class II	1	Ongoing
8 Dec 2023	Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)	Device	Class II	1	Ongoing
8 Dec 2023	Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)	Device	Class II	1	Ongoing
7 Dec 2023	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 Software key	Device	Class II	8	Ongoing
3 Nov 2023	Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris Allura 9 722022 Allura Xper FD10 OR Table 722023…	Device	Class II	2	Ongoing
15 Aug 2023	Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems	Device	Class II	1	Ongoing
20 Jul 2023	Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.	Device	Class II	1	Ongoing
19 Jul 2023	Allura Xper series	Device	Class II	3	Ongoing
30 Jun 2023	Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems	Device	Class II	1	Ongoing
12 Jun 2023	Allura Xper FD10 and FD20. X-ray Imaging System.	Device	Class II	2	Ongoing
21 Mar 2023	Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion…	Device	Class II	1	Ongoing
20 Feb 2023	SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6	Device	Class II	2	Ongoing
2 Dec 2021	Zenition 50, Model #718096	Device	Class II	3	Ongoing
26 May 2021	Azurion systems with software release R1.x	Device	Class II	1	Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Type and class

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: events for each product type
Type		Events
Device		59

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: events in each class
Class		Events
Class II		58
Class I		1

Share of the events of the firm in Class I: 2%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 59

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., by the year that the recall started. The largest year is 2025, with 19 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: FDA recalls. https://recallregister.com/firm/philips-medical-systems-nederland-b-v/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have?: Class II: 58 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.?: FDA event 99422, which the firm started on 16 Jul 2026. The first product in the record is: Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed…
How many FDA recalls of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have the status Ongoing?: 59 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.