BEUDAMED
    FDA Recall Terminated

    GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.

    Recall: Z-0700-2013 · Initiated December 11, 2012

    Recall

    Recall Number
    Z-0700-2013
    Event Number
    63972
    Firm
    AMS Innovative Center San Jose
    FEI Number
    2937094
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 11, 2012
    Posted
    January 22, 2013
    Terminated
    February 13, 2014
    Address
    3070 Orchard Dr, San Jose, CA, 95134-2011

    Description

    GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia.

    Reason

    During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.

    Action

    AMS sent "NOTICE OF DEVICE FIELD CORRECTIVE ACTION" letters dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-408-456-3320 for questions about this notification.

    Distribution

    Worldwide Distribution.

    Quantity

    389 devices, all model numbers.