Philips Azurion 7 B12 Recall for X-ray Imaging Issues

Source: FDA · United States

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Philips Medical Systems is recalling 670 units of Azurion 7 B12 medical devices due to potential failures in X-ray imaging initiation when using the wired foot switch.

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

This notice was issued by FDA on April 16, 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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Philips Azurion 7 B12 Recall

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 affected devices.

Which Products Are Affected

The affected products are Azurion 7 B12 medical devices with the following system codes: (1) 722067, (2) 722225, and (3) 722235. The recall involves 670 units total, with 106 units in the US and 564 units outside the US. Specific UDIs are: (1) 00884838085350, (2) 00884838099265, and (3) 00884838116788. The recall number is Z-1675-2026, and distribution was nationwide in the US as well as in various international countries.

What You Should Do

Consumers should follow the initial firm notification, which was sent via letter, and contact the recalling firm, Philips Medical Systems Nederland B.V., for further instructions on the voluntary recall.

Why This Matters

This recall affects medical devices used in healthcare settings, potentially impacting the reliability of X-ray imaging and patient safety in the US and internationally.

Source

FDA recall notice Z-1675-2026

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 Medical Systems is recalling 670 units of Azurion 7 B12 medical devices due to potential failures in X-ray imaging initiation when using the wired foot switch.
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.