The Recall Desk

FDA (Devices) recall action 93781

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled 2 products on 2024-02-28

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
2024-02-28
Critical
0
Units
—

Why these products were recalled

Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2024-02-28

    Philips Azurion X-ray Systems Disk Bay May Fail and Prevent Imaging

    The disk bay component in certain Philips Azurion x-ray systems may fail, potentially preventing diagnostic imaging and delaying procedures. Affected units have been distributed worldwide.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2024-02-28

    Philips Allura Xper X-ray systems disk bay component may malfunction

    Philips has recalled certain Allura Xper interventional X-ray systems because the disk bay component may fail, potentially preventing system operation and imaging procedures.

    Product
    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026;
    Category
    Distribution
    49 states