Recall Z-1778-2013 ยท FTC Light, Ultraviolet, Dermatological
National Biological Corp
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.
| Date | Jul 19, 2013 (initiated Apr 9, 2013) |
| Status | Terminated |
| Reason | The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device. |
| Root cause | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903660 | DERMALIGHT PSORACOMB Solitec GmbH, Jul 17, 1991 |