- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)85, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)55, 2. Azurion 3 M15; Model: 722064; UDI: (01)00884838085282(21)209, (01)00884838085282(21)201, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)61, (01)00884838085282(21)161, (01)00884838085282(21)162, (01)00884838085282(21)169, (01)00884838085282(21)131, (01)00884838085282(21)190, (01)00884838085282(21)220, (01)00884838085282(21)173, (01)00884838085282(21)89, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)9, (01)00884838085282(21)102, (01)00884838085282(21)137, (01)00884838085282(21)84, (01)00884838085282(21)78, (01)00884838085282(21)49, (01)00884838085282(21)213, (01)00884838085282(21)212, (01)00884838085282(21)193, (01)00884838085282(21)214, (01)00884838085282(21)180, (01)00884838085282(21)185, (01)00884838085282(21)186, (01)00884838085282(21)127, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)81, (01)00884838085282(21)200, (01)00884838085282(21)179, (01)00884838085282(21)156, (01)00884838085282(21)230, (01)00884838085282(21)176, (01)00884838085282(21)150, (01)00884838085282(21)149, (01)00884838085282(21)44, (01)00884838085282(21)184, (01)00884838085282(21)6, (01)00884838085282(21)10, (01)00884838085282(21)82, (01)00884838085282(21)35, (01)00884838085282(21)69, (01)00884838085282(21)39, (01)00884838085282(21)66, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)55, (01)00884838085282(21)36, (01)00884838085282(21)94, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)183, (01)00884838085282(21)70, (01)00884838085282(21)50, (01)00884838085282(21)138, (01)00884838085282(21)151, (01)00884838085282(21)5, (01)00884838085282(21)208, (01)00884838085282(21)57, (01)00884838085282(21)222, (01)00884838085282(21)98, (01)00884838085282(21)79, (01)00884838085282(21)65, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)75, (01)00884838085282(21)46, (01)00884838085282(21)101, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)91, (01)00884838085282(21)74, (01)
- Units affected
- 1651 units (592 US, 1359 OUS)
- Distribution pattern
- 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;
- Firm location
- Best, Netherlands
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2227-2026
- Recall initiated
- April 28, 2026
- FDA classification date
- May 21, 2026
- FDA report date
- May 27, 2026
- FDA event ID
- 98801
- Last updated on HTM Vibe
- July 23, 2026