FDA-Device2026-07-22Class IIPROCESSING DEFECT
Daavlin Photera 600 3-D phototherapy device recalled for incorrect UV output calibration
What this means
The Photera 600 3-D ultraviolet phototherapy device used to treat skin disorders has a calibration error in how it calculates UV output. A sensor setting was incorrectly applied, causing the device to deliver lower UV intensity than intended. This affects 212 units distributed nationwide.
- Check if your device serial number matches the recall list (starts with 6-09 and ends with NB8CL, NB12CL, or similar).
- Contact Daavlin Distributing Company for instructions on correcting the calibration or obtaining a replacement.
- Do not use the device until the calibration issue is resolved.
The agency's original wording
Hazard
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
212 units
Manufactured in
205 W Bement St, Bryan, OH, United States
Products
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2744-2026More Daavlin recalls
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