Device recall: 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…

Class II FDA enforcement event 98977. Recall start date: 7 Dec 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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 7 Dec 2023. The firm address in the FDA record is in Best. FDA put the recall in Class II. FDA event 98977 has 8 product records. The first FDA enforcement report date is 10 Jun 2026. The record gives the status Ongoing.

FDA enforcement report The 8 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 Nationwide distribution.

Recalling firm

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

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

Products

8 product records in the event.

FDA event 98977: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2284-2026	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	16 units	Class II	Ongoing	10 Jun 2026
Z-2285-2026	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 Software key	27 units	Class II	Ongoing	10 Jun 2026
Z-2286-2026	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 key	3 units	Class II	Ongoing	10 Jun 2026
Z-2287-2026	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 key	51 units	Class II	Ongoing	10 Jun 2026
Z-2288-2026	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 Software key	51 units	Class II	Ongoing	10 Jun 2026
Z-2289-2026	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 Software key	156 units	Class II	Ongoing	10 Jun 2026
Z-2290-2026	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 Software key	167 units	Class II	Ongoing	10 Jun 2026
Z-2291-2026	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 Software key	31 units	Class II	Ongoing	10 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 2023: 917
Share of these events in Class II: 88%
Product records in this event: 8Median 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
18 May 2026	Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for	Device	Class II	2
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

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

Official channels

FDA enforcement report Z-2284-2026The 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.

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

Cite this page

Recall Register. FDA enforcement event 98977. https://recallregister.com/fda/ii/98977/. 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 Nationwide distribution.
What quantity of product is in FDA event 98977?: The event has 8 product records. The first record gives this quantity: 16 units
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 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.