BEUDAMED
    FDA Recall Terminated

    HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

    Recall: Z-1309-2008 · Initiated February 19, 2008

    Recall

    Recall Number
    Z-1309-2008
    Event Number
    46834
    Firm
    National Biological Corp
    FEI Number
    1521608
    Product Code
    FTC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 19, 2008
    Posted
    August 28, 2008
    Terminated
    September 20, 2011
    Address
    23700 Mercantile Rd, Beachwood, OH, 44122-5900

    Description

    HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

    Reason

    Software allows operator to override "low line voltage" error warning and store light intensity value.

    Action

    National Biological sent an "Important safety reminders for your Houva DermaSense phototherapy device" letters, dated 2/11/08 to users. It states that the user should collect a "Profile" of the light energy and record it on a daily/weekly flow chart. The chart should be in plain view so each operator can clearly determine the units output. If an error message appears in the display panel, treatment should not be continued unless the phototherapy booth operator was able to identify and correct the cause of the error. Make sure both breakers are in the "ON" position before starting up the unit each morning and before giving treatment.

    Distribution

    Worldwide distribution --- USA including states of: CA, DE, FL, GA, ID, IL, IN, MA, MI, MN, NC, NH, NY, OH, OR, PA, TX, VA, WA and WI, and country of Canada.

    Quantity

    48 Units