Philips Recalls Azurion 7 M12 Systems Due to Unexpected Table Movement Hazard

Source: FDA · Worldwide

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Philips Medical Systems is recalling Azurion 7 M12 systems because the patient table may move unexpectedly during geometry resets, even when locks are active.

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

This notice was issued by FDA on February 24, 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 7 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, potentially creating a safety hazard during medical procedures.

Which Products Are Affected

The recall involves 1,979 units globally, including 365 units distributed across the United States. The following models and software versions are affected:

  • Product Name: Azurion 7 M12 System
  • Model Numbers: 722078, 722223, 722233
  • Software Versions: All versions (R1.X, R2.X, R3.X)
  • UDI-DIs: 884838085251, 884838099241, 884838116764
  • Serial Numbers: All serial numbers for the specified models are included.

What You Should Do

As this is a firm-initiated voluntary recall, healthcare facilities using these systems should be aware of the risk of unexpected table movement when utilizing the Reset Geometry function. Operators should exercise caution even when table locks are engaged. For further information regarding the recall (Recall Number: Z-1348-2026), facilities should refer to the official notifications provided by Philips Medical Systems.

Why This Matters

Unexpected movement of a medical procedure table poses a risk of injury to both patients and clinical staff. The failure of the table lock to prevent movement during a geometry reset could lead to complications during sensitive medical imaging or interventions.

Source

FDA - Recall Number: Z-1348-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips Medical Systems is recalling Azurion 7 M12 systems because the patient table may move unexpectedly during geometry resets, even when locks are 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.