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Recall Observatory FDA recall evidence

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

April 08, 2013

Class III

Product summary

Firm
National Biological Corp
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

    reason.no_named_rule · v1.0.0

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