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Philips Azurion X-Ray Tube Cooling Unit
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MEDICAL DEVICE RECALLMODERATE

Philips Azurion X-Ray Tube Cooling Unit

Philips is recalling X-ray tube cooling units in Azurion systems due to hose degradation and potential oil leakage.

What to do

Contact your local Philips service representative to schedule a cooling unit inspection and repair.

Posted
Updated
Recall No.
Z-2227-2026
Agency
Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall ID
98801
Status
ONGOING

Why it was recalled

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.

How to identify it

UPC 00884838085275 00884838085275 00884838085275 00884838085275 00884838085275 00884838085275 00884838085275 00884838085275

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).

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification