BEUDAMED
    FDA Recall Terminated

    Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile)

    Recall: Z-1101-2007 · Initiated February 13, 2007

    Recall

    Recall Number
    Z-1101-2007
    Event Number
    38075
    Firm
    Sunnex Inc.
    FEI Number
    1000583780
    Product Code
    FTA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 13, 2007
    Posted
    July 24, 2007
    Terminated
    January 6, 2009
    Address
    3 Huron Dr, Natick, MA, 01760-1314

    Description

    Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile)

    Reason

    Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

    Action

    Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users

    Distribution

    Nationwide

    Quantity

    30 lamps