PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Integris-Allura system

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.

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);

On April 28, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue. 2. In case the affected system has been transferred to another organization, please send a copy of this URGENT Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 3. Keep this letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 4. If you experience the issue described in this letter, please report it to your local Philips representative. Actions planned by Philips IGT Systems to correct the issue Starting in Q1 2027, Philips will replace the deaeration hose in the CU3101 tube cooling unit in all affected systems. Your local Philips representative will contact you to schedule a visit to replace the deaeration hose once available.

• FDA enforcement recordOfficial FDA database entry for Z-2229-2026
• FDA device classification · OWBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.