Philips Medical Systems Recalls Azurion 7 B12 Systems Due to Unexpected Table Movement

Source: FDA · Worldwide

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Philips Medical Systems has issued a voluntary recall for 655 Azurion 7 B12 medical imaging systems worldwide due to a software issue that causes unexpected table movement.

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 7 B12 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.

Which Products Are Affected

The recall impacts a total of 655 units, with 106 located in the United States and 549 distributed internationally. The following Azurion 7 B12 System models and software versions are included:

  • Model Numbers: 722067, 722225, 722235
  • Software Versions: All versions (R1.X, R2.X, R3.X)
  • UDI-DIs: 884838085350, 884838099265, 884838116788
  • Serial Numbers: All serial numbers for the listed models are affected.

What You Should Do

Healthcare providers and facilities using the Azurion 7 B12 System should exercise caution when using the "Reset Geometry" button, particularly regarding the potential for unexpected table movement. Owners of the affected units should contact Philips Medical Systems Nederland B.V. at their Veenpluis 4-6 address in the Netherlands or through their official service channels for guidance on necessary software updates or corrective actions.

Why This Matters

This Class II recall highlights a mechanical safety risk where unintended equipment movement could potentially cause injury to patients or medical staff during imaging procedures.

Source

Information provided by the FDA. Recall Number: Z-1346-2026.

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 voluntary recall for 655 Azurion 7 B12 medical imaging systems worldwide due to a software issue that causes unexpected table movement.
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.