PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3
Philips Medical Systems Nederland B.V. is addressing a degradation issue in the deaeration hoses of X-ray tube cooling units (type CU3101) manufactured between 2016 and 2020, which may lead to oil leakage and suboptimal cooling performance. Under these conditions, the Azurion system defaults to low-dose fluoroscopy and displays a specific error message that persists after a system restart.
This affects clinical engineering and radiology departments utilizing Azurion 3 and Azurion 7 systems equipped with CU3101 cooling units, as well as regulatory and quality departments responsible for managing medical device recalls and hardware longevity.
The degradation of an internal component leading to a forced 'low-dose' operational state suggests a potential impact on procedural efficiency and imaging performance. From a regulatory perspective, this emphasizes the importance of monitoring component-level aging in cooling systems and ensuring that error messages clearly communicate hardware-based failure modes to the end-user.
Quality units should verify if any on-site CU3101 cooling units fall within the February 2016 to May 2020 manufacturing window. Clinical teams must be briefed that the 'Low load fluoroscopy flavor selected' message indicates a hardware degradation issue that cannot be resolved via a system restart.
Class II. Reason: 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 automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.. Product: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).. Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (Best Netherlands). Status: Ongoing.
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