Philips Recalls Azurion 5 M20 Systems Due to Unexpected Table Movement Hazard

Source: FDA · Worldwide

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Philips Medical Systems has issued a recall for Azurion 5 M20 systems because the medical table may move unexpectedly when the Reset Geometry button is pressed.

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 5 M20 system. The recall was triggered by a defect where the system's table may move unexpectedly when the "Reset Geometry" button is pressed. This movement can occur even when a table lock is actively engaged, potentially creating a safety hazard during medical procedures.

Which Products Are Affected

The recall involves the Azurion 5 M20 System with the following specific details:

  • Model Numbers: 722228, 722232, and 722281 (OUS only).
  • Software Versions: All versions, including R1.X, R2.X, and R3.X.
  • UDI-DIs: 884838099234 and 884838116757.
  • Serial Numbers: All serial numbers for the listed models are affected.
  • Quantity: 922 units total (101 units in the United States and 821 units distributed internationally).

This recall affects units distributed nationwide in the U.S. and in over 100 countries worldwide, including the United Kingdom, Germany, Japan, and Australia.

What You Should Do

This is a firm-initiated voluntary recall. Healthcare providers and facilities utilizing the Azurion 5 M20 system should be alert to the risk of unexpected table movement when utilizing the Reset Geometry function. Users should follow all communication and corrective action instructions provided by Philips Medical Systems Nederland B.V. regarding this equipment.

Why This Matters

Unexpected movement of a medical table during a procedure can lead to patient injury or the disruption of critical medical tasks. The failure of the table lock to prevent movement during a geometry reset poses a specific risk to clinical stability.

Source

Information provided by the FDA. Recall Number: Z-1351-2026.

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 has issued a recall for Azurion 5 M20 systems because the medical table may move unexpectedly when the Reset Geometry button is pressed.
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.