BEUDAMED
    FDA Enforcement Class II Ongoing

    Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)

    Recall: Z-2661-2023 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-2661-2023
    Event ID
    92893
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 11, 2023
    Initiation Date
    August 10, 2023
    Classification Date
    September 29, 2023
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)

    Reason

    Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

    Code Info

    Model-UDI: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" 00815686021122; INS-5611 SPiN Perc¿ Localization Needle - 2cm, 5/Bx 00815686021146; INS-5610 SPiN Perc¿ Localization Needle - 1cm, 5/Bx 00815686021139; INS-5600 SPiN Perc¿ Biopsy Needle Guide Kit, 5/Bx (includes INS-5029) 00815686020736. All serial numbers and all lot numbers

    Distribution

    Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

    Quantity

    9961 units