BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus Pleuravideoscope, Model LTF-160

    Recall: Z-1762-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1762-2020
    Event ID
    85208
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    March 23, 2020
    Classification Date
    April 22, 2020
    Termination Date
    November 30, 2021
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Olympus Pleuravideoscope, Model LTF-160

    Reason

    There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.

    Code Info

    All Serial numbers

    Distribution

    US Nationwide

    Quantity

    265 total