The Recall Desk

FDA (Devices) recall action 98826

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled 2 products on 2026-06-03

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2026-06-03
Critical
0
Units
—

Why these products were recalled

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

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

1–2 of 2

  • HighFDA (Devices)··2026-06-03

    Philips Allura system hard drives may degrade and lose imaging

    Philips Allura Xper interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    Product
    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allur
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    Distribution
    0 states
  • HighFDA (Devices)··2026-06-03

    Philips Azurion system hard drives may degrade and lose imaging

    Philips Azurion interventional X-ray systems are being recalled because hard drives in the system PCs may lose performance as they age, potentially causing loss of imaging functionality.

    Product
    Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (
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    Distribution
    0 states