The Recall Desk

FDA (Devices) recall action 98801

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled 3 products on 2026-05-27

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2026-05-27
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • HighFDA (Devices)··2026-05-27

    Integris-Allura X-ray systems with degraded deaeration hoses recalled

    Philips is recalling Integris-Allura X-ray systems because deaeration hoses in X-ray tube cooling units may degrade, causing oil leakage that reduces cooling performance and triggers a system shutdown to low-dose mode.

    Product
    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
    Category
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    0 states
  • HighFDA (Devices)··2026-05-27

    Azurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage

    The deaeration hose in Philips Azurion X-ray tube cooling units may degrade over time and leak oil, affecting cooling performance and automatically triggering low-dose fluoroscopy mode.

    Product
    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).
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    Distribution
    0 states
  • ModerateFDA (Devices)··2026-05-27

    Philips Allura X-ray Systems Deaeration Hose Degradation Recall

    Deaeration hoses in Philips Allura X-ray tube cooling units may degrade and leak oil, reducing cooling performance. Affected units were manufactured between February 2016 and May 2020.

    Product
    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, 72
    Category
    Distribution
    0 states