Philips Azurion 3 M12 Recall for X-ray Imaging Issues

Source: FDA · United States

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Philips is recalling 298 units of the Azurion 3 M12 medical device due to potential failures in initiating X-ray imaging with the wired foot switch, affecting systems distributed nationwide in the US.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch on the Azurion 3 M12 systems, leading to a voluntary recall classified as Class II by the FDA.

Which Products Are Affected

The affected products are Azurion 3 M12 systems with the following System Codes: (1) 722063, (2) 722221, and (3) 722229. The Universal Device Identifier (UDI) for these systems is 00884838085275. A total of 298 units are involved, with 27 units in the US and 271 units outside the US. Specific serial numbers are associated with each system code, and distribution includes nationwide in the US as well as international locations. The recall number is Z-1673-2026.

What You Should Do

Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., located at Veenpluis 6, Best, Netherlands, for instructions on the recall.

Why This Matters

This recall addresses a potential malfunction in critical medical imaging equipment, which could impact diagnostic procedures and patient care, highlighting the importance of device reliability in healthcare settings.

Source

FDA recall notice for event ID 98434, available at the FDA website under recall number Z-1673-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips is recalling 298 units of the Azurion 3 M12 medical device due to potential failures in initiating X-ray imaging with the wired foot switch, affecting systems distributed nationwide in the US.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.