FDA-Device2026-07-22Class IIPROCESSING DEFECT
Daavlin Photera 600 phototherapy device recalled for incorrect UV output calibration
OTHERNationwide distribution
Daavlin Photera 600 phototherapy device recalled for incorrect UV output
The Photera 600 ultraviolet phototherapy device was found to have an error in how it calculates UV output. A sensor setting was incorrect, causing the device to deliver lower UV levels than intended. This affects 26 units with specific serial numbers distributed nationwide.
- Check if your device serial number matches the list provided by Daavlin Distributing Company
- Contact Daavlin Distributing Company for instructions on repair or replacement
- Do not use an affected unit until corrected by 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
26 units
Manufactured in
205 W Bement St, Bryan, OH, United States
Products
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2743-2026More Daavlin Distributing Company recalls
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