Philips Medical Systems Recalls Azurion 3 M12 Systems Due to Unexpected Table Movement
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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 April 6, 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 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, Devices.
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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