Recall Weekly← all recalls
FDA-Device2026-05-27Class IIPROCESSING DEFECT

Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk

Philips
OTHERNationwide distribution

Philips Integris-Allura X-ray systems recalled for cooling unit degradation

A rubber hose inside the X-ray tube cooling unit (type CU3101) on certain Philips Integris-Allura systems can degrade and leak oil over time. This reduces cooling performance and causes the system to automatically switch to low-dose mode with a "Tube cooler problem" message that cannot be cleared by restarting. The affected cooling units were manufactured between February 2016 and May 2020.

  • If you operate one of the affected Philips Integris-Allura models, check the serial number against the FDA notice
  • Contact Philips Medical Systems for inspection or replacement of the cooling unit
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
25 units (11 US, 14 OUS)
Manufactured in
Veenpluis 6, Best, Netherlands
Products
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2229-2026

More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief