Philips Medical Systems Recalls Azurion 7 B20 Systems Due to Unexpected Table Movement

Source: FDA · United States

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Philips Medical Systems Nederland B.V. has issued a voluntary recall for Azurion 7 B20 systems because the table may move unexpectedly during geometry resets, posing a potential safety risk.

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

This notice was issued by FDA on April 6, 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.

What Happened

Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 7 B20 System. The recall was issued because, under certain conditions, the system's table may move unexpectedly when the "Reset Geometry" button is pressed. This unintended movement can occur even when a table lock is currently active.

Which Products Are Affected

The recall affects a total of 1,503 units worldwide, with 326 units distributed across the United States. The following products are included in this recall:

  • Product Name: Azurion 7 B20 System
  • Model Numbers: 722068, 722226, 722236
  • Software Versions: All versions (R1.X, R2.X, R3.X)
  • UDI-DIs: 884838085367, 884838099272, 884838116801
  • Serial Numbers: All serial numbers are affected.

What You Should Do

Healthcare facilities and operators using the Azurion 7 B20 System should exercise caution when using the "Reset Geometry" function. Users should be aware that the table may move despite the activation of a table lock. For further information regarding remediation or software updates, contact Philips Medical Systems Nederland B.V. directly at their headquarters in Veenpluis 4-6, Best, Netherlands.

Why This Matters

Unexpected movement of medical equipment during clinical procedures poses a risk of injury to both patients and medical staff. The failure of the table lock to prevent movement during a geometry reset is a significant safety concern for surgical and diagnostic environments.

Source

Information provided by the FDA under Recall Number Z-1347-2026.

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. has issued a voluntary recall for Azurion 7 B20 systems because the table may move unexpectedly during geometry resets, posing a potential safety risk.
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.