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Terminated

Dermalight 80 Model Number UVB-083, 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.

FDA Recall Z-1779-2013 · Posted 2013-07-19

Recall StatusTerminated
Product CodeFTC
Date Initiated2013-04-08
Date Terminated2014-02-24
Product Quantity6 units

Reason for Recall

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

Firm 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].

Root Cause

Labeling mix-ups

Distribution Pattern

US distribution including the states of: AL, CA, MN, and NC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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