Philips cooling-hose issue reaches FDA recall list
FDA records list Class 2 recalls for Azurion, Allura, and Integris-Allura systems tied to possible degradation of CU3101 X-ray tube-cooling-unit hoses.
FDA records list 3 Class 2 recalls for Philips interventional fluoroscopic X-ray systems because deaeration hoses in CU3101 X-ray tube-cooling units may degrade over time. The affected entries cover Azurion, Allura, and Integris-Allura systems.
Philips Medical Systems Nederland initiated the recalls on April 28, 2026, and FDA posted them on May 21. The recalls remain open and classified, according to FDA records.
The issue involves deaeration hoses manufactured between February 2016 and May 2020. FDA records say degradation may lead to oil leakage, which can affect X-ray tube cooling performance.
When oil flow falls below a threshold, the system switches automatically to low-dose fluoroscopy and displays: “Low load fluoroscopy flavor selected: Tube cooler problem.” FDA records state that restarting the system does not resolve the condition.
The 3 FDA recall entries list 4,990 units in commerce. The Azurion entry covers 1,651 units, including 592 in the U.S.; the Allura entry covers 3,314 units, including 816 in the U.S.; and the Integris-Allura entry covers 25 units, including 11 in the U.S.
FDA records classify the cause as component design or selection. Philips instructed customers to circulate the urgent medical device correction letter to all system users and keep the letter with system documentation until the correction is completed.
Philips plans to replace the deaeration hose in the CU3101 tube-cooling unit in all affected systems starting in Q1 2027. Local Philips representatives will contact customers to schedule the replacement, according to the FDA records.
Health Canada published a related alert on May 6 and said that, under normal conditions, leaked oil is contained within the system. In rare cases, more significant leakage could allow oil to reach hot surfaces and generate fumes that may activate environmental detection systems.
FDA defines a Class 2 recall as a situation in which exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Company:Philips
Sources
- Class 2 Device Recall Azurion. Regulatory filing
- Class 2 Device Recall Allura. Regulatory filing
- Class 2 Device Recall IntegrisAllura. Regulatory filing
- Azurion and Allura Xper Systems. Government document
- Recalls Background and Definitions. Government document
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Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
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