Device recall: Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034…

Class II FDA enforcement event 99223. Recall start date: 18 May 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. started this device recall on 18 May 2026. The firm address in the FDA record is in Best. FDA put the recall in Class II. FDA event 99223 has 2 product records. The first FDA enforcement report date is 24 Jun 2026. The record gives the status Ongoing.

FDA enforcement report The 2 product records

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.

Distribution

In the words of FDA.

US and ROW.

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, Netherlands.

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

FDA records how the recall started: FDA Mandated.

Products

2 product records in the event.

FDA event 99223: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2411-2026	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.		Class II	Ongoing	24 Jun 2026
Z-2412-2026	Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura…		Class II	Ongoing	24 Jun 2026

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class II: 87%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 59

Other events of the firm

Other FDA enforcement events of PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Initiated	Product (first record)	Type	Class	Records
16 Jul 2026	Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 72	Device	Class II	1
16 Jul 2026	Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Versio	Device	Class II	1
29 Jun 2026	Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscop	Device	Class II	1
17 Jun 2026	Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbe	Device	Class II	3
30 Apr 2026	Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222),	Device	Class II	2
28 Apr 2026	Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions an	Device	Class II	1
28 Apr 2026	Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (	Device	Class II	3
31 Mar 2026	Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230),	Device	Class II	1
19 Mar 2026	Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to	Device	Class II	1
5 Mar 2026	Vue Motion V12. Product Number: 1017979.	Device	Class II	1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: all 59 events

Official channels

FDA enforcement report Z-2411-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 99223. https://recallregister.com/fda/ii/99223/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US and ROW.
How did the recall start?: The FDA record says: FDA Mandated
How many device recalls of 2026 have the same class?: 87% of the 572 device events that started in 2026 are in Class II.
How many FDA recalls does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have?: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is the recalling firm in 59 enforcement events on this register. This event is 1 of them.