Z-1778-2013Class III

Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that...

Name: Z-1778-2013 Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that...
Creator: National Biological Corp
Published: 2013-04-09
License: https://open.fda.gov/license/

National Biological Corp. / initiated 2013-04-09 / Terminated / root cause: labeling and UDI

FDA source

National Biological Corp began a recall of 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... on 2013-04-09. FDA classified it as Class III and gives the reason as "The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1778-2013
Classification: Class III
Status: Terminated
Initiated: 2013-04-09
Posted: 2013-07-19
Terminated: 2014-02-24
Recalling firm: National Biological Corp.
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.
Product code: FTC Light, Ultraviolet, Dermatological
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.
Root cause tag: labeling and UDI
FDA 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 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].
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.
Product codes and lots: The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1778-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1778-2013	Class III	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-19

Product code FTC

K903660Class IIDermalight PsoracombSolitec GmbH / cleared 1991-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)