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Recall Observatory FDA recall evidence

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

April 09, 2013

Class III

Product summary

Firm
National Biological Corp
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

    reason.no_named_rule · v1.0.0

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