Events

Recall of Dermalight 80. UVB080

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by National Biological Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65488
  • Event Risk Class
    Class 3
  • Event Number
    Z-1778-2013
  • Event Initiated Date
    2013-04-09
  • Event Date Posted
    2013-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119131
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Lamp, infrared, non heating - Product Code FTC
  • 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: infor@PhototherapyExperts.com.

Device

Dermalight 80. UVB080
  • Model / Serial
    The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    National Biological Corp

Manufacturer

National Biological Corp
  • Manufacturer Address
    National Biological Corp, 23700 Mercantile Rd, Beachwood OH 44122-5900
  • Manufacturer Parent Company (2017)
    National Biological Corporation
  • Source
    USFDA