BEUDAMED
    FDA Enforcement Class III Terminated

    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036

    Recall: Z-0162-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0162-2020
    Event ID
    83902
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xintec Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 30, 2019
    Initiation Date
    October 29, 2017
    Classification Date
    October 18, 2019
    Termination Date
    April 28, 2021
    Address
    1660 S Loop Rd, Alameda, CA, 94502-7091, United States

    Description

    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036

    Reason

    It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.

    Code Info

    Lot # 21144, Use by 08/10/2021

    Distribution

    PA and VA

    Quantity

    45 lasers