BEUDAMED
    FDA Enforcement Class II Terminated

    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source

    Recall: Z-2455-2012 · Reported October 3, 2012

    Enforcement

    Recall Number
    Z-2455-2012
    Event ID
    63009
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Linvatec Corp. dba ConMed Linvatec
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 3, 2012
    Initiation Date
    May 20, 2011
    Classification Date
    September 25, 2012
    Termination Date
    September 26, 2012
    Address
    11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States

    Description

    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source

    Reason

    Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are intended to be used with an endoscope to provide illumination during endoscopic procedures.

    Code Info

    GCT

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, DK, HK, IN, IT, KR, MY, RU, CO, VN, ZA.

    Quantity

    1