Philips Azurion X-ray Tube Cooling Unit Deaeration Hose
Philips recalls Azurion systems: deaeration hose may leak oil, causing cooling failure and low-dose fluoroscopy lockout.
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. If your system displays the 'Tube cooler problem' message, contact Philips immediately for service.
Why it was recalled
Philips is recalling certain Azurion systems because the deaeration hose in the X-ray tube cooling unit (type CU3101) may degrade over time, potentially causing oil leakage. Oil leakage can reduce cooling performance, and when oil flow drops below a threshold, the system automatically switches to low-dose fluoroscopy and displays a 'Tube cooler problem' 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.
| Product | Recall # | UDI-DI |
|---|---|---|
| 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). | Z-2227-2026 | 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275 |
| 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); | Z-2229-2026 | 4059001008 |
| 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 FD20/2 | Z-2228-2026 | 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030, 00884838059030 |
| 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); | – | 00884838059030, 921, 1440, 1328, 1292, 1428, 1396, 298, 1432, 1425, 1398, 1397, 1391, 1395, 314, 1297, 946, 1424, 1244, 1122, 1198, 1421, 1423, 1438, 697, 1192, 1326, 402, 1148, 1439, 1431, 1404, 1140, 1429, 1430, 1403, 1393, 1402, 406, 1434 (+2127 more, see the official notice) |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification