BEUDAMED
    FDA Recall Terminated

    Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)

    Recall: Z-0873-2007 · Initiated April 5, 2007

    Recall

    Recall Number
    Z-0873-2007
    Event Number
    37793
    Firm
    Vision Systems Group, A Div of Viking Systems
    FEI Number
    1000305720
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 5, 2007
    Posted
    June 6, 2007
    Terminated
    June 7, 2007
    Address
    134 Flanders Rd, Westborough, MA, 01581-1023

    Description

    Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)

    Reason

    Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure

    Action

    Viking notified 2 distributors and 1 end user by telephone on 3/15/07. Viking representatives performed on site visit to perform inspection and replace units if needed.

    Distribution

    Nationwide to CA and NC

    Quantity

    4