BEUDAMED
    FDA Enforcement Class II Ongoing

    Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.

    Recall: Z-0139-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0139-2025
    Event ID
    95406
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2024
    Initiation Date
    September 6, 2024
    Classification Date
    October 22, 2024
    Address
    Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, N/A, N/A, Japan

    Description

    Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.

    Reason

    If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

    Code Info

    UDI-DI: 04540217058327, 04540217049066, 04540217058143 Serial Numbers: 41EFCD7AC001, 41E58C773001, 41EFCD79C001, 41EFCD78B001, 41EFC73A9001, 41EFCD7D4001, 41E58C76B001, 41EFC73D9001, 41EFCD77C001, 41EFC73A5001, 41EFC73C5001, 41EFCD79A001, 41EFCD7A6001.

    Distribution

    US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.

    Quantity

    13