fda_recall · device_recall · high

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063),…

Event date
2026-05-27 00:00:00Z
Observed
2026-07-09 22:52:25Z
Source ID
Z-2227-2026
Payload hash
10937fd145040c71effc45f4

Summary

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system a… Status: Ongoing.

Informational only. Not legal, financial, or medical advice.