BEUDAMED
    8 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X

    FDA Enforcement
    Class II ·Ongoing·Philips North America·April 3, 2024

    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 22, 2024

    Patient Information Center iX; Software Version Number: 4.5.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 28, 2026

    Change Healthcare Cardiology Hemodynamics software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    Change Healthcare Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    McKesson Cardiology Hemo software

    FDA Enforcement
    Class II ·Ongoing·A L I Technologies Ltd·January 22, 2025

    Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

    FDA Enforcement
    Class II ·Ongoing·Philips North America·October 16, 2024

    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

    FDA Enforcement
    Class II ·Ongoing·Philips North America·April 3, 2024