BEUDAMED
    FDA Recall Terminated

    American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134

    Recall: Z-0131-2008 · Initiated June 18, 2007

    Recall

    Recall Number
    Z-0131-2008
    Event Number
    38377
    Firm
    AMS Innovative Center San Jose
    FEI Number
    2937094
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 18, 2007
    Posted
    February 26, 2008
    Terminated
    March 23, 2010
    Address
    3070 Orchard Dr, San Jose, CA, 95134-2011

    Description

    American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134

    Reason

    Control knob break: The knob used to finely control the direction of the laser energy may break.

    Action

    American Medical Systems, Inc. (AMS) issued Important: Medical Device Recall AMS Greenlight ADDStat Fibers notification letters to customers who have purchased the product on June 28, 2007. The customer letter requests recipients that the product use be discontinued, and the fibers be returned. The firm will send replacements.

    Distribution

    Worldwide Distribution - USA and Singapore.

    Quantity

    611 units