FDA-Device2026-07-22Class IIPROCESSING DEFECT
Daavlin Photera 400 phototherapy device recalled for incorrect UV output calibration
What this means
The Photera 400 ultraviolet phototherapy device uses a sensor to measure and control UV output for treating skin disorders. A calibration error caused the sensor to report incorrect UV levels, which means patients may have received different doses than intended.
- Contact Daavlin Distributing Company if you own a Photera 400 with serial number 4-01440NB10CL or 4-01441NB10CL
- Do not use the device until you receive instructions from the manufacturer
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
2 units
Manufactured in
205 W Bement St, Bryan, OH, United States
Products
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2742-2026More Daavlin recalls
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