Thousands of Philips interventional systems subject to FDA recall

Thousands of Philips interventional imaging systems have been added to the U.S. Food and Drug Administration’s list of medical device recalls. 

On May 21, the Allura and Azurion fluoro systems made their way onto the list due to an issue that could interfere with the systems’ ability to cool themselves. The notice indicates that the deaeration hoses in the X-ray tube cooling units (type CU3101) may be vulnerable to degrading over time, preventing them from properly cooling and leading to oil leaks. 

“Oil leakage may affect the cooling performance of the X-ray tube,” the FDA’s warning reads. “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.” 

The Class 2 recall only applies to systems with deaeration hoses manufactured between February 2016 and May 2020.  

Philips issued urgent medical device correction letters to affected customers in late April. Those messages indicated that there is no quick, in-house fix for the issue and that it cannot be resolved by rebooting. Philips signaled that it would begin replacing the faulty components for affected customers during the first quarter of 2027. These repairs will be coordinated through customers’ designated Philips representatives. 

The affected systems are in distribution globally. Nearly 10,000 are believed to be impacted. Class 2 recalls are designated for issues that have the potential to cause medical harm, though the probability of serious consequences is remote. 

For more information, click here.