BEUDAMED
    FDA Recall 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 · Initiated April 9, 2013

    Recall

    Recall Number
    Z-1778-2013
    Event Number
    65488
    Firm
    National Biological Corp
    FEI Number
    1521608
    Product Code
    FTC
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 9, 2013
    Posted
    July 19, 2013
    Terminated
    February 24, 2014
    Address
    23700 Mercantile Rd, Beachwood, OH, 44122-5900

    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.

    Action

    The firm, National Biological, sent an "VOLUNTARY PRODUCT RECALL NOTIFICATION" letter dated May 10, 2013 to its consignees/customers by UPS or other delivery service with a signature required. The letter described the product, problem and actions to be taken. Consignees/customers who do not respond to the letter will be contacted via telephone. The customers were instructed to check within your household to determine if you have any of the listed product; immediately destroy the incorrect User Manual, it is not necessary to return the product; record the Customer Name and or the Dermalight-80 serial number and complete and return the enclosed Verification Form, even if you do not have any User Manuals to destroy. Please contact your National Biological Corporation sales representative if you have any questions regarding this recall, any of our products, or would like assistance with the recall call 216-831-0600 or 800-338-5045 email: [email protected].

    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