BEUDAMED
    FDA Enforcement Class II Ongoing

    SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

    Recall: Z-1103-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1103-2023
    Event ID
    91291
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2023
    Initiation Date
    December 13, 2022
    Classification Date
    February 7, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

    Reason

    A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

    Code Info

    UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412

    Distribution

    FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA

    Quantity

    13 units