fda_recall · device_recall · high

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Integris-Allura system; System Code Description (Model Numbers): Integris CV Ces…

Event date
2026-05-27 00:00:00Z
Observed
2026-07-09 22:52:27Z
Source ID
Z-2229-2026
Payload hash
4accda64413f350e76bda994

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.