FDAFDA · Food and drugs·Recall number Z-1779-2013
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.
Published July 31, 2013 · Recall initiated: April 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- National Biological Corp
- Distributor
- US distribution including the states of: AL, CA, MN, and NC.
- Lot
- The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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