BEUDAMED
    FDA Recall Terminated

    Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

    Recall: Z-0028-2007 · Initiated August 29, 2006

    Recall

    Recall Number
    Z-0028-2007
    Event Number
    36188
    Firm
    Lumenis Inc.
    FEI Number
    2914019
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2006
    Posted
    October 12, 2006
    Terminated
    January 22, 2007
    Address
    2400 Condensa St, Santa Clara, CA, 95051-0901

    Description

    Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

    Reason

    Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.

    Action

    On 8/26/06, the firm initiated the recall and its notification was via letters and phone calls requesting return of affected product.

    Distribution

    Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada.

    Quantity

    10,815