FDA-Device2024-02-28Class II
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; Azurion 7 M20 722079;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
1,993 US; 2,662 ROW
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
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; Azurion 7 M20 722079;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1145-2024Don't want to check this manually?
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