Philips Medical Systems Recalls Azurion 3 M12 Systems Due to Unexpected Table Movement

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.