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FDA-Device2026-05-27Class IIPROCESSING DEFECT

Philips Azurion X-ray systems recalled for cooling hose degradation risk

Philips
OTHERNationwide distribution

Philips Azurion X-ray systems recalled for cooling failure risk

A cooling hose in certain Philips Azurion X-ray systems may degrade over time and leak oil, reducing cooling performance. When oil levels drop too far, the system automatically switches to low-dose mode and cannot be fixed by restarting.

  • Check if your Azurion system was manufactured between February 2016 and May 2020 and contains a CU3101 cooling unit
  • Contact Philips Medical Systems for inspection or replacement of the affected cooling hose
  • Do not attempt to restart the system if you see the 'Tube cooler problem' message
Hazard

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.

Sold states
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;
Affected count
1651 units (592 US, 1359 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2026

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