Device product
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.
Z-1779-2013
Product summary
- Event
- Event 65494
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1779-2013
Official wording
Reason: The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
Code information: The following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021.
Distribution pattern: US distribution including the states of: AL, CA, MN, and NC.
Derived failure modes
-
Unknown
The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.