Philips Medical Systems Recalls Azurion 7 B12 Systems Due to Unexpected Table Movement

What Happened

Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 7 B12 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.

Which Products Are Affected

The recall impacts a total of 655 units, with 106 located in the United States and 549 distributed internationally. The following Azurion 7 B12 System models and software versions are included:

• Model Numbers: 722067, 722225, 722235
• Software Versions: All versions (R1.X, R2.X, R3.X)
• UDI-DIs: 884838085350, 884838099265, 884838116788
• Serial Numbers: All serial numbers for the listed models are affected.

What You Should Do

Healthcare providers and facilities using the Azurion 7 B12 System should exercise caution when using the “Reset Geometry” button, particularly regarding the potential for unexpected table movement. Owners of the affected units should contact Philips Medical Systems Nederland B.V. at their Veenpluis 4-6 address in the Netherlands or through their official service channels for guidance on necessary software updates or corrective actions.

Why This Matters

This Class II recall highlights a mechanical safety risk where unintended equipment movement could potentially cause injury to patients or medical staff during imaging procedures.

Source

Information provided by the FDA. Recall Number: Z-1346-2026.