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U.S. Department of Health and Human Services

Class 3 Device Recall Dermalight 80. UVB080

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 Class 3 Recall
Dermalight 80. UVB080
see related information
Date Posted July 19, 2013
Recall Status1 Terminated on February 24, 2014
Recall Number Z-1778-2013
Recall Event ID 65488
Premarket Notification
510(K) Number
K903660 
Product Classification Light, Ultraviolet, Dermatological - Product Code FTC
Product 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.
Code Information The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.
Recalling Firm/
Manufacturer
National Biological Corp
23700 Mercantile Rd
Beachwood, Ohio 44122-5900
Manufacturer Reason
for Recall
The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
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.
Quantity in Commerce 124 units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTC and Original Applicant = SOLITEC GMBH
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