Device 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.
Z-1778-2013
Product summary
- Event
- Event 65488
- Status
- Terminated
- Classification
- Class III
- Quantity
- 124 units
- Official record key
device-enforcement:Z-1778-2013
Official wording
Reason: The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
Code information: The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.