Daavlin Distributing Company: Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

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).

Details from the source

Reason for recall: 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). Distribution: US Nationwide distribution. Quantity: 212 units Lot/code info: 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, 6-0936

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.