FDA-Device2026-07-22Class IIPROCESSING DEFECT
Daavlin Photera 400 phototherapy device recalled for incorrect UV output calibration
OTHERNationwide distribution
Daavlin Photera 400 phototherapy device recalled for incorrect UV calibration
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
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).
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 Distributing Company recalls
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