Philips Recalls Azurion 7 M20 Systems Due to Unexpected Table Movement

What Happened

Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 7 M20 System. The recall was prompted by a defect where, under certain conditions, the medical table may move unexpectedly when the “Reset Geometry” button is pressed. This movement can occur even when a table lock is actively engaged, posing a potential risk during medical procedures.

Which Products Are Affected

The recall affects a total of 5,136 units globally, including 1,743 units in the United States and 3,393 units distributed internationally. The following specific models and software versions are included:

• Product Name: Azurion 7 M20 System
• Model Numbers: 722079, 722224, 722234, and 722282 (Outside US only)
• Software Versions: All versions (R1.X, R2.X, R3.X)
• UDI-DIs: 884838085268, 884838099258, 884838116771
• Serial Numbers: All serial numbers for the listed models are affected
• Recall Number: Z-1349-2026

What You Should Do

As this is a firm-initiated voluntary recall of medical devices, healthcare facilities and clinical operators using the Azurion 7 M20 System should be aware of the risk of unexpected movement when utilizing the “Reset Geometry” function. Operators should exercise caution and follow any specific safety instructions provided by Philips Medical Systems regarding software updates or hardware adjustments.

Why This Matters

Unexpected movement of a medical table during a clinical procedure can lead to patient injury or disrupt delicate medical tasks. The FDA has classified this as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences.

Source

This information is provided by the FDA under recall event ID 98326.