Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Summary
The FDA issued a Class II for Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorder by Daavlin Distributing Company. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2744-2026
Action Date
2026-07-22
Status
Ongoing
Category
device
Product Description
Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
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.
Quantity Affected: 212 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-05
Company
Bryan, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 102 device recalls issued in the same week, part of 365 device-related FDA actions this month.
Daavlin Distributing Company has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Daavlin Distributing Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Daavlin Distributing Company have FDA actions?
Daavlin Distributing Company has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2744-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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