The Recall Desk

FDA (Devices) recall action 93783

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

Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.

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

1–2 of 2

  • HighFDA (Devices)··2024-02-28

    Philips Allura Xper Interventional X-ray System Display and Imaging Malfunction

    A framegrabber card malfunction in Philips Allura Xper interventional X-ray systems may cause display failures, preventing proper visualization of medical images and delaying procedures.

    Product
    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-02-28

    Philips Azurion Interventional X-ray Systems framegrabber card may fail to display images

    The framegrabber card in Philips Azurion interventional X-ray systems may fail to display diagnostic images properly, potentially delaying procedures.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223;
    Category
    Distribution
    0 states