United StatesPhotera 400, Photera 600, and Photera 600 3‑D phototherapy devices distributed nationwide by Daavlin Distributing Company are affected; the recall covers specific serial numbers listed in the notice. They were recalled because the calibrated output was not calculating correctly due to an incorrect UV sensor GAIN (GAIN appeared as “4/5” instead of “7,” resulting in counts of about 1,000 instead of about 5,000).
What's being recalled
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Recalling firm: Daavlin Distributing Company, Bryan, OH, United States.
How to identify it
Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL. Serial Numbers: 6-09033NB4CL, 6-09037NB4CL, 6-09031NB4CL, 6-09538NB4CL, 6-09038NB4CL, 6-09039NB4CL, 6-09040NB4CL, 6-09041NB4CL, 6-09035NB4CL, 6-09034NB4CL, 6-09030NB4CL, 6-09026NB4CL, 6-09023NB4CL, 6-09028NB4CL, 6-09025NB4CL, 6-09043NB4CL, 6-09029NB4CL, 6-09044NB4CL, 6-09022NB4CL, 6-09027NB4CL, 6-09036NB4CL, 6-09045NB4CL, 6-09024NB4CL, 6-07827NB4CL, 6-09539NB4CL, 6-09042NB4CL. Serial Numbers: 6-09278NB8CL, 6-09271NB8CL, 6-09055NB8CL, 6-09113NB8CL, 6-09204NB8CL, 6-09207NB8CL, 6-09116NB8CL, 6-09263NB8CL, 6-09272NB8CL, 6-09118NB8CL, 6-09275NB8CL, 6-09264NB8CL, 6-09060NB8CL, 6-09122NB8CL, 6-09216NB8CL, 6-09125NB8CL, 6-09353NB8CL, 6-09346NB8CL, 6-09128NB8CL, 6-09129NB8CL, 6-09133NB8CL, 6-09134NB8CL, 6-09266NB8CL, 6-09215NB8CL, 6-09355NB8CL, 6-09137NB8CL, 6-09359NB8CL, 6-09343NB8CL, 6-09140NB8CL, 6-09142NB8CL, 6-09143NB8CL, 6-09273NB8CL, 6-09065NB8CL, 6-09144NB8CL, 6-09237NB8CL, 6-09225NB8CL, 6-09145NB8CL, 6-09147NB8CL, 6-09148NB8CL, 6-09378NB8CL, 6-09252NB8CL, 6-09051NB8CL, 6-09260NB8CL, 6-09250NB8CL, 6-09149NB8CL, 6-09238NB8CL, 6-09212NB8CL, 6-09277NB8CL, 6-09048NB8CL, 6-09274NB8CL, 6-09259NB8CL, 6-09224NB8CL, 6-09057NB8CL, 6-09436NB12CL, 6-09438NB8CL, 6-09434NB12CL, 6-09270NB8CL, 6-09115NB8CL, 6-09111NB8CL, 6-09435NB12CL, 6-09124NB8CL, 6-09332NB12CL, 6-09223NB8CL, 6-09219NB8CL, 6-09234NB8CL, 6-09063NB8CL, 6-09232NB8CL, 6-09479NB12CL, 6-09373NB8CL, 6-09127NB8CL, 6-09247NB8CL, 6-09135NB8CL, 6-09344NB8CL, 6-09221NB8CL, 6-09050NB8CL, 6-09336NB12CL, 6-09049NB8CL, 6-09068NB8CL, 6-09331NB12CL, 6-09240NB8CL, 6-09235NB8CL, 6-09365NB8CL, 6-09205NB8CL, 6-09345NB8CL, 6-09202NB8CL, 6-09136NB8CL, 6-09201NB8CL, 6-09249NB8CL, 6-09437NB8CL, 6-09208NB8CL, 6-09434NB12CL, 6-09503NB8CL, 6-09132NB8CL, 6-09228NB8CL, 6-09257NB8CL, 6-09058NB8CL, 6-09210NB8CL, 6-09054NB8CL, 6-09062NB8CL, 6-09254NB8CL, 6-09256NB8CL, 6-09255NB8CL, 6-09229NB8CL, 6-09062NB8CL, 6-09203NB8CL, 6-09364NB8CL, 6-09236NB8CL, 6-09141NB8CL, 6-09357NB8CL, 6-09241NB8CL…
The 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).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)