Philips Recalls Azurion 5 M20 Systems Due to Unexpected Table Movement Hazard

What Happened

Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 5 M20 system. The recall was triggered by a defect 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 actively engaged, potentially creating a safety hazard during medical procedures.

Which Products Are Affected

The recall involves the Azurion 5 M20 System with the following specific details:

• Model Numbers: 722228, 722232, and 722281 (OUS only).
• Software Versions: All versions, including R1.X, R2.X, and R3.X.
• UDI-DIs: 884838099234 and 884838116757.
• Serial Numbers: All serial numbers for the listed models are affected.
• Quantity: 922 units total (101 units in the United States and 821 units distributed internationally).

This recall affects units distributed nationwide in the U.S. and in over 100 countries worldwide, including the United Kingdom, Germany, Japan, and Australia.

What You Should Do

This is a firm-initiated voluntary recall. Healthcare providers and facilities utilizing the Azurion 5 M20 system should be alert to the risk of unexpected table movement when utilizing the Reset Geometry function. Users should follow all communication and corrective action instructions provided by Philips Medical Systems Nederland B.V. regarding this equipment.

Why This Matters

Unexpected movement of a medical table during a procedure can lead to patient injury or the disruption of critical medical tasks. The failure of the table lock to prevent movement during a geometry reset poses a specific risk to clinical stability.

Source

Information provided by the FDA. Recall Number: Z-1351-2026.