Philips Recalls Azurion 7 M12 Systems Due to Unexpected Table Movement Hazard

What Happened

Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 7 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, potentially creating a safety hazard during medical procedures.

Which Products Are Affected

The recall involves 1,979 units globally, including 365 units distributed across the United States. The following models and software versions are affected:

• Product Name: Azurion 7 M12 System
• Model Numbers: 722078, 722223, 722233
• Software Versions: All versions (R1.X, R2.X, R3.X)
• UDI-DIs: 884838085251, 884838099241, 884838116764
• Serial Numbers: All serial numbers for the specified models are included.

What You Should Do

As this is a firm-initiated voluntary recall, healthcare facilities using these systems should be aware of the risk of unexpected table movement when utilizing the Reset Geometry function. Operators should exercise caution even when table locks are engaged. For further information regarding the recall (Recall Number: Z-1348-2026), facilities should refer to the official notifications provided by Philips Medical Systems.

Why This Matters

Unexpected movement of a medical procedure table poses a risk of injury to both patients and clinical staff. The failure of the table lock to prevent movement during a geometry reset could lead to complications during sensitive medical imaging or interventions.

Source

FDA - Recall Number: Z-1348-2026