PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion system

Recalling company

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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 – may cause temporary or medically reversible health consequences

Recall date

Apr 28, 2026

Reported

May 27, 2026

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 Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Yemen;

Status

Ongoing

Quantity

1651 units (592 US, 1359 OUS)

Lot / codes

1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)62, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)19, (01)00884838085275(21)18, (01)00884838085275(21)17, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)101, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)93, (01)00884838085275(21)115, (01)00884838085275(21)73, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)72, (01)00884838085275(21)38, (01)00884838085275(21)21, (01)00884838085275(21)78, (01)00884838085275(21)23, (01)00884838085275(21)76, (01)00884838085275(21)63, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)51, (01)00884838085275(21)92, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)54, (01)00884838085275(21)46, (01)00884838085275(21)26, (01)00884838085275(21)71, (01)00884838085275(21)106, (01)00884838085275(21)83,

Company location

Best

Recall type

Voluntary: Firm initiated

Recall number

Z-2227-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2227-2026 in the FDA Enforcement Report. Also see FDA recall press releases.