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Philips Azurion X-ray Tube Cooling Unit
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MEDICAL DEVICE RECALLMODERATE

Philips Azurion X-ray Tube Cooling Unit

Philips recalls Azurion systems over cooling unit hose degradation that may cause oil leakage and force low-dose mode.

What to do

Contact Philips Medical Systems for a free replacement of the deaeration hose in the X-ray tube cooling unit. Do not attempt to repair the system yourself.

Posted
Updated
Recall No.
Z-2227-2026
Agency
FDA
Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall ID
98801
Status
ONGOING

Why it was recalled

Philips Medical Systems is recalling certain Azurion systems because the deaeration hose in the X-ray tube cooling unit (type CU3101, manufactured February 2016–May 2020) may degrade over time, causing oil leakage. Oil leakage can reduce cooling performance, forcing the system into low-dose fluoroscopy mode with a persistent error message that cannot be resolved by restarting.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUPCRecall #
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).00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275Z-2227-2026
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);4059001008Z-2229-2026
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/200884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030Z-2228-2026
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);––

Where it was sold

Distributed nationwide.

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification