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Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Class II
Recalling firm
Daavlin Distributing Company
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).
Affected products (lot / model / serial)
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.
Units affected
212 units
Distribution pattern
US Nationwide distribution.
Firm location
Bryan, OH, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Telephone
Product type
Devices
Status
Ongoing
Recall number
Z-2744-2026
Recall initiated
March 5, 2026
FDA classification date
July 15, 2026
FDA report date
July 22, 2026
FDA event ID
99331
Last updated on HTM Vibe
July 28, 2026
View on openFDA