Daavlin Distributing Company recalls Photera 600 3-D, phototherapy device; Ultraviolet Lamp For D

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)

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, 6-09364NB8CL, 6-09236NB8CL, 6-09141NB8CL, 6-09357NB8CL, 6-09241NB8CL, 6-09213NB8CL, 6-09330NB12CL, 6-09226NB8CL, 6-09245NB8CL, 6-09379NB8CL, 6-09276NB8CL, 6-09381NB8CL, 6-09358NB8CL, 6-09110NB8CL, 6-09067NB8CL, 6-09380NB8CL, 6-09112NB8CL, 6-09261NB8CL, 6-09371NB8CL, 6-09114NB8CL, 6-09504NB8CL, 6-09514NB8CL, 6-09524NB8CL, 6-09117NB8CL, 6-09119NB8CL, 6-09377NB8CL, 6-09268NB8CL, 6-09269NB8CL, 6-09262NB8CL, 6-09120NB8CL, 6-09121NB8CL, 6-09123NB8CL, 6-09126NB8CL, 6-09356NB8CL, 6-09138NB8CL, 6-09246NB8CL, 6-09214NB8CL, 6-09265NB8CL, 6-09239NB8CL, 6-09374NB8CL, 6-09046NB8CL, 6-09347NB8CL, 6-09231NB8CL, 6-09146NB8CL, 6-09505NB8CL, 6-09244NB8CL, 6-09248NB8CL, 6-09369NB8CL, 6-09502NB8CL, 6-09372NB8CL, 6-09508NB8CL, 6-09047NB8CL, 6-09342NB8CL, 6-09501NB8CL, 6-09349NB8CL, 6-09360NB8CL, 6-09053NB8CL, 6-09375NB8CL, 6-09253NB8CL, 6-09066NB8CL, 6-09370NB8CL, 6-09333NB12CL, 6-09329NB12CL, 6-09334NB12CL, 6-09242NB8CL, 6-09350NB8CL, 6-09354NB8CL, 6-09064NB8CL, 6-09227NB8CL, 6-09243NB8CL, 6-09341NB8CL, 6-09130NB8CL, 6-09061NB8CL, 6-09131NB8CL, 6-09222NB8CL, 6-09206NB8CL, 6-09200NB8CL, 6-09139NB8CL, 6-09363NB8CL, 6-09217NB8CL, 6-09059NB8CL, 6-09506NB8CL, 6-09509NB8CL, 6-09376NB8CL, 6-09368NB8CL, 6-09362NB8CL, 6-09052NB8CL, 6-09220NB8CL, 6-09258NB8CL, 6-09209NB8CL, 6-09352NB8CL, 6-09218NB8CL, 6-09361NB8CL, 6-09211NB8CL, 6-09233NB8CL, 6-09230NB8CL, 6-09562NB12CL, 6-09335NB12CL, 6-09348NB8CL, 6-09513NB8CL, 6-09267NB8CL, 6-09351NB8CL, 6-09344NB8CL, 6-09365NB8CL, 6-09234NB8CL, 6-09331NB12CL, 6-09221NB8CL.