BEUDAMED
    FDA Enforcement Class III Terminated

    Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

    Recall: Z-1778-2013 · Reported July 31, 2013

    Enforcement

    Recall Number
    Z-1778-2013
    Event ID
    65488
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    National Biological Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2013
    Initiation Date
    April 9, 2013
    Classification Date
    July 19, 2013
    Termination Date
    February 24, 2014
    Address
    23700 Mercantile Rd, N/A, Beachwood, OH, 44122-5900, United States

    Description

    Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

    Reason

    The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.

    Code Info

    The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.

    Distribution

    Worldwide distribution: US (nationwide) including states of: AL, CA, CO, CT, FL, GA, IA, ID, IL, LA, MA, MN, MO, MS, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI; and countries of: Canada, Brazil, Malaysia, and Mexico.

    Quantity

    124 units