FDA Device recall Z-1778-2013
Dermalight 80 Model Number UVB-080, one unit per box
- FDA Device
- Class III
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class III recall of Dermalight 80 Model Number UVB-080, one unit per box by National Biological, citing the incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1778-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-04-09 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | National Biological |
| Distribution | US |
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.
Reason
The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
Identifiers
| code_info | The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1778-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.