Philips Medical Systems Recalls Azurion 7 B20 Systems Due to Unexpected Table Movement
Philips Medical Systems Nederland B.V. has issued a voluntary recall for Azurion 7 B20 systems because the table may move unexpectedly during geometry resets, posing a potential safety risk.
What Happened
Philips Medical Systems Nederland B.V. has initiated a voluntary recall of the Azurion 7 B20 System. The recall was issued because, under certain conditions, the system’s table may move unexpectedly when the “Reset Geometry” button is pressed. This unintended movement can occur even when a table lock is currently active.
Which Products Are Affected
The recall affects a total of 1,503 units worldwide, with 326 units distributed across the United States. The following products are included in this recall:
- Product Name: Azurion 7 B20 System
- Model Numbers: 722068, 722226, 722236
- Software Versions: All versions (R1.X, R2.X, R3.X)
- UDI-DIs: 884838085367, 884838099272, 884838116801
- Serial Numbers: All serial numbers are affected.
What You Should Do
Healthcare facilities and operators using the Azurion 7 B20 System should exercise caution when using the “Reset Geometry” function. Users should be aware that the table may move despite the activation of a table lock. For further information regarding remediation or software updates, contact Philips Medical Systems Nederland B.V. directly at their headquarters in Veenpluis 4-6, Best, Netherlands.
Why This Matters
Unexpected movement of medical equipment during clinical procedures poses a risk of injury to both patients and medical staff. The failure of the table lock to prevent movement during a geometry reset is a significant safety concern for surgical and diagnostic environments.
Source
Information provided by the FDA under Recall Number Z-1347-2026.
Source: FDA Official Notice