BEUDAMED
    FDA Enforcement Class II Terminated

    OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.

    Recall: Z-2866-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2866-2017
    Event ID
    77653
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Xintec Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    June 23, 2017
    Classification Date
    August 2, 2017
    Termination Date
    June 20, 2018
    Address
    1660 S Loop Rd, N/A, Alameda, CA, 94502-7091, United States

    Description

    OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.

    Reason

    It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.

    Code Info

    all codes.

    Distribution

    Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.

    Quantity

    4343 units