Philips Medical Systems Recalls Azurion 3 M15 Systems Due to Unexpected Table Movement

What Happened

Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 3 M15 System. The recall was issued following reports that, under certain conditions, the patient table may move unexpectedly when the “Reset Geometry” button is pressed. This unintended movement can occur even if a table lock is currently active, potentially creating a hazard during medical procedures.

Which Products Are Affected

The recall involves a total of 802 units, with 45 units distributed within the United States and 757 units distributed internationally. The following models and software versions are affected:

• Product Name: Azurion 3 M15 System
• Model Numbers: 722064, 722222, 722230, and 722280 (OUS only)
• Software Versions: All versions (R1.X, R2.X, R3.X)
• UDI-DIs: 884838085282, 884838099210, 884838116733
• Serial Numbers: All serial numbers for the specified models are included in this recall.

Distribution was worldwide, including US nationwide and over 100 other countries across Europe, Asia, Africa, and the Americas.

What You Should Do

Healthcare facilities and operators using the Azurion 3 M15 System should identify if their equipment matches the model numbers and software versions listed above. As this is a firm-initiated voluntary recall, users should follow all specific instructions and safety protocols provided by Philips Medical Systems Nederland B.V. regarding the use of the Reset Geometry function.

Why This Matters

Unexpected movement of a patient table during a medical procedure poses a risk of injury to both patients and clinical staff. This Class II recall indicates that while the risk of serious adverse health consequences may be remote, the defect could cause temporary or medically reversible health issues.

Source

Information provided by the FDA. Recall Number: Z-1345-2026.