BEUDAMED
    FDA Recall Terminated

    GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.

    Recall: Z-0130-2008 · Initiated April 17, 2007

    Recall

    Recall Number
    Z-0130-2008
    Event Number
    38336
    Firm
    AMS Innovative Center San Jose
    FEI Number
    2937094
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 17, 2007
    Posted
    March 20, 2008
    Terminated
    March 23, 2010
    Address
    3070 Orchard Dr, San Jose, CA, 95134-2011

    Description

    GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134.

    Reason

    Component missing: Some products were issued without thermal protection switches.

    Action

    AMS issued Important: Medical Device Correction letters, dated April 17, 2007, to its US and international consignees by mail, instructing them to return an acknowledgement form. The letter informs customers that some HPS systems may lack a motor overload switch, that the firm believes that there is no immediate safety issue, and installation of the MOL switch will be conducted during normal preventive maintenance. AMS expects to complete installation of the switches by end of August 2007.

    Distribution

    Worldwide Distribution - USA, Italy, France, Germany, Spain, UK, Denmark, Sweden, Australia, India, Japan, Greece, Switzerland, Saudi Arabia, Thailand, Turkey, Singapore, Taiwan/Hong Kong (China), and Austria.

    Quantity

    169 units