BEUDAMED
    FDA Recall 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 · Initiated October 29, 2017

    Recall

    Recall Number
    Z-0162-2020
    Event Number
    83902
    Firm
    Xintec Corp
    FEI Number
    2938889
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    October 29, 2017
    Posted
    October 18, 2019
    Terminated
    April 28, 2021
    Address
    1660 S Loop Rd, Alameda, CA, 94502-7091

    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.

    Action

    On October 29, 2017, the firm contacted consignees via phone. During the phone the following information was provided: 1. Convergent has become aware of an issue affecting one lot of the fibers that have been purchased recently. The affected product is the CGH1080F fibers with lot number 21144. It has been determined that the fibers in that batch 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 with it is plugged in. There have been no reports of adverse reactions related to this issue. Please return the products to Convergent. In return, we will send replacement fibers to you.

    Distribution

    PA and VA

    Quantity

    45 lasers