Philips Medical Systems Recalls Azurion 3 M12 Systems Due to Unexpected Table Movement

Source: FDA · Worldwide

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Philips Medical Systems Nederland B.V. is recalling Azurion 3 M12 systems because the table may move unexpectedly when the Reset Geometry button is pressed, even if a table lock is active.

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

This notice was issued by FDA on February 25, 2026 and geographically references Worldwide. 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 MEDICAL SYSTEMS NEDERLAND B.V. has initiated a voluntary recall of the Azurion 3 M12 System. The recall was issued because, under certain conditions, the system's table may move unexpectedly when the "Reset Geometry" button is pressed. This movement can occur even when a table lock is currently active, posing a potential safety risk during medical procedures.

Which Products Are Affected

A total of 291 units are affected by this recall, including 27 units in the United States and 264 units distributed internationally. The recall includes all serial numbers for the following models and software versions:

  • Product Name: Azurion 3 M12 System
  • Model Numbers: 722063, 722221, 722229
  • Software Versions: All versions (R1.X, R2.X, R3.X)
  • UDI-DIs: 884838085275, 884838099203, 884838116726

What You Should Do

Healthcare facilities utilizing the Azurion 3 M12 System should exercise caution when using the "Reset Geometry" function. As this is a firm-initiated voluntary recall, users should follow all communication and corrective action instructions provided by Philips Medical Systems Nederland B.V. regarding software updates or safety protocols.

Why This Matters

Unexpected movement of a medical table during clinical use can lead to patient injury or interfere with the precision required during medical imaging and procedures. The FDA has classified this as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA. Recall Number: Z-1344-2026.

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 Nederland B.V. is recalling Azurion 3 M12 systems because the table may move unexpectedly when the Reset Geometry button is pressed, even if a table lock is active.
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 Worldwide. 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.