Philips Medical Systems Nederland B.v. Veenpluis: Interventional Fluoroscopic X-ray System

Recall Summary Philips is recalling certain Azurion interventional X-ray systems because a hose in the X-ray tube cooling unit may degrade and leak oil over time, reducing cooling performance. When oil levels drop too low, the system automatically switches to low-dose mode and displays an error message that cannot be fixed by restarting. This recall affects systems manufactured between February 2016 and May 2020 and distributed across the United States, Canada, and numerous other countries worldwide.

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis
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).
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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-04-28
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican...

Recall details on Nibble Recalls: https://trynibble.app/recalls/826c23e5-94a4-4745-add3-f489299553fb