Philips Medical Systems Recalls Azurion 5 M12 Systems Over Unexpected Table Movement Hazard

What Happened

Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 5 M12 medical imaging system. The recall was triggered by a software issue where the system’s table may move unexpectedly when the “Reset Geometry” button is pressed. This movement can occur even when a table lock is active, potentially leading to unintended positioning during use.

Which Products Are Affected

The recall affects the Azurion 5 M12 System with the following specifications:

• Model Numbers: 722227 and 722231
• Software Versions: All versions (R1.X, R2.X, R3.X)
• UDI-DIs: 884838099227, 884838099258, 884838116740
• Serial Numbers: All units associated with the affected models
• Quantity: 326 units total (10 units in the United States and 316 units distributed internationally)

Distribution was worldwide, including nationwide coverage in the United States and over 100 other countries.

What You Should Do

Facilities and healthcare providers using the Azurion 5 M12 System should be aware of the risk of unexpected movement when utilizing the Reset Geometry function. While the table lock is intended to prevent movement, it may not function as expected in this specific scenario. Owners of these devices should contact Philips Medical Systems Nederland B.V. for guidance on necessary software updates or safety protocols. The firm is located at Veenpluis 4-6, Best, Netherlands.

Why This Matters

Unexpected movement of a medical table during a procedure poses a risk of injury to patients or clinical staff, particularly if the movement occurs while safety locks are assumed to be engaged.

Source

Information provided by the FDA. Recall Number: Z-1350-2026.