| Date Initiated by Firm | December 10, 2025 |
|---|
| Date Posted | June 02, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2295-2026 |
|---|
| Recall Event ID |
98817 |
| 510(K)Number | K220840 |
|---|
| Product Classification |
Light, ultraviolet, dermatological - Product Code FTC
|
| Product | Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4 |
|---|
| Code Information |
Serial Numbers:
2-03409NB4DT
2-03560NB4DT
2-03798NB4DT
2-03472NB4DT
2-03315NB4DT
2-03726NB4DT
2-03396NB4DT
2-03320NB4DT
2-03447NB4DT
2-03564NB4DT
2-03516NB4DT
2-03467NB4DT
2-03292NB4DT
2-03371NB4DT
2-03433NB4DT
2-03446NB4DT
2-03343NB4DT
2-03400NB4DT
2-03342NB4DT
2-03547NB4DT
2-03449NB4DT
2-03685NB4DT
2-03574NB4DT
2-03392NB4DT
2-03345NB4DT
2-03431NB4DT
2-03608NB4DT
2-03530NB4DT
2-03501NB4DT
2-03362NB4DT
2-03603NB4DT
2-03713NB4DT
2-03508NB4DT
2-03341NB4DT
2-03418NB4DT
2-03721NB4DT
2-03662NB4DT
2-03679NB4DT
2-03591NB4DT
2-03319NB4DT
2-03411NB4DT
2-03505NB4DT
2-03335NB4DT
2-03585NB4DT
2-03556NB4DT
2-03355NB4DT
2-03664NB4DT
2-03515NB4DT
2-03424NB4DT
2-03470NB4DT
2-03386NB4DT
2-03455NB4DT
2-03401NB4DT
2-03391NB4DT
2-03578NB4DT
2-03388NB4DT
2-03632NB4DT
2-03615NB4DT
2-03434NB4DT
2-03454NB4DT
2-03387NB4DT
2-03390NB4DT
2-03569NB4DT
2-03541NB4DT
2-03509NB4DT
2-03789NB4DT
2-03804NB4DT
2-03439NB4DT
2-03367NB4DT
2-03442NB4DT
2-03750NB4DT
2-03349NB4DT
2-03510NB4DT
2-03538NB4DT
2-03559NB4DT
2-03539NB4DT
2-03491NB4DT
2-03502NB4DT
2-03629NB4DT
2-03383NB4DT
2-03496NB4DT
2-03619NB4DT
2-03511NB4DT
2-03670NB4DT
2-03565NB4DT
2-03581NB4DT
2-03479NB4DT
2-03348NB4DT
2-03534NB4DT
2-03484NB4DT
2-03802NB4DT
2-03504NB4DT
2-03457NB4DT
2-03417NB4DT
2-03482NB4DT
2-03318NB4DT
2-03503NB4DT
2-03518NB4DT
2-03350NB4DT
2-03686NB4DT
2-03317NB4DT
2-03687NB4DT
2-03507NB4DT
2-03663NB4DT
2-03658NB4DT
2-03330NB4DT
2-03489NB4DT
2-03451NB4DT
2-03486NB4DT
2-03465NB4DT
2-03346NB4DT
2-03598NB4DT
2-03377NB4DT
2-03414NB4DT
2-03422NB4DT
2-03531NB4DT
2-03329NB4DT
2-03579NB4DT
2-03817NB4DT
2-03613NB4DT
2-03322NB4DT
2-03570NB4DT
2-03397NB4DT
2-03326NB4DT
2-03347NB4DT
2-03469NB4DT
2-03483NB4DT
2-03359NB4DT
2-03344NB4DT
2-03436NB4DT
2-03711NB4DT
2-03437NB4DT
2-03459NB4DT
2-03384NB4DT
2-03389NB4DT
2-03592NB4DT
2-03432NB4DT
2-03823NB4DT
2-03616NB4DT
2-03498NB4DT
2-03512NB4DT
2-03809NB4DT
2-03647NB4DT
2-03606NB4DT
2-03722NB4DT
2-03818NB4DT
2-03589NB4DT
2-03356NB4DT
2-03583NB4DT
2-03799NB4DT
2-03487NB4DT
2-03398NB4DT
2-03775NB4DT
2-03427NB4DT
2-03533NB4DT
2-03676NB4DT
2-03468NB4DT
2-03684NB4DT
2-03413NB4DT
2-03716NB4DT
2-03374NB4DT
2-03430NB4DT
2-03473NB4DT
2-03575NB4DT
2-03339NB4DT
2-03666NB4DT
2-03323NB4DT
2-03471NB4DT
2-03334NB4DT
2-03310NB4DT
2-03631NB4DT
2-03405NB4DT
2-03720NB4DT
2-03372NB4DT
2-03463NB4DT
2-03353NB4DT
2-03563NB4DT
2-03419NB4DT
2-03725NB4DT
2-03621NB4DT
2-03336NB4DT
2-03312NB4DT
2-03806NB4DT
2-03572NB4DT
2-03597NB4DT
2-03370NB4DT
2-03435NB4DT
2-03354NB4DT
2-03555NB4DT
2-03440NB4DT
2-03376NB4DT
2-03610NB4DT
2-03653NB4DT
2-03749NB4DT
2-03380NB4DT
2-03558NB4DT
2-03462NB4DT
2-03313NB4DT
2-03517NB4DT
2-03790NB4DT
2-03513NB4DT
2-03602NB4DT
2-03683NB4DT
2-03561NB4DT
2-03514NB4DT
2-03604NB4DT
2-03445NB4DT
2-03423NB4DT
2-03338NB4DT
2-03375NB4DT
2-03361NB4DT
2-03543NB4DT
2-03492NB4DT
2-03801NB4DT
2-03497NB4DT
2-03601NB4DT
2-03824NB4DT
2-03477NB4DT
2-03545NB4DT
2-03813NB4DT
2-03557NB4DT
2-03426NB4DT
2-03428NB4DT
2-03394NB4DT
2-03645NB4DT
2-03842NB4DT
2-03528NB4DT
2-03321NB4DT
2-03478NB4DT
2-03438NB4DT
2-03369NB4DT
2-03661NB4DT
2-03682NB4DT
2-03412NB4DT
2-03351NB4DT
2-03673NB4DT
2-03453NB4DT
2-03605NB4DT
2-03461NB4DT
2-03495NB4DT
2-03582NB4DT
2-03540NB4DT
2-03594NB4DT
2-03612NB4DT
2-03810NB4DT
2-03364NB4DT
2-03609NB4DT
2-03672NB4DT
2-03529NB4DT
2-03379NB4DT
2-03554NB4DT
2-03490NB4DT
2-03407NB4DT
2-03586NB4DT
2-03600NB4DT
2-03618NB4DT
2-03421NB4DT
2-03659NB4DT
2-03671NB4DT
2-03448NB4DT
2-03607NB4DT
2-03402NB4DT
2-03485NB4DT
2-03480NB4DT
2-03420NB4DT
2-03328NB4DT
2-03408NB4DT
2-03481NB4DT
2-03625NB4DT
2-03331NB4DT
2-03614NB4DT
2-03646NB4DT
2-03668NB4DT
2-03800NB4DT
2-03499NB4DT
2-03753NB4DT
2-03520NB4DT
2-03464NB4DT
2-03316NB4DT
2-03580NB4DT
2-03675NB4DT
2-03665NB4DT
2-03546NB4DT
2-03590NB4DT
2-03544NB4DT
2-03415NB4DT
2-03719NB4DT
2-03456NB4DT
2-03532NB4DT
2-03385NB4DT
2-03452NB4DT
2-03593NB4DT
2-03366NB4DT
2-03759NB4DT
2-03506NB4DT
2-03425NB4DT
2-03660NB4DT
2-03360NB4DT
2-03519NB4DT
2-03688NB4DT
2-03537NB4DT
2-03429NB4DT
2-03406NB4DT
2-03340NB4DT
2-03311NB4DT
2-03562NB4DT
2-03474NB4DT
2-03655NB4DT
2-03466NB4DT
2-03595NB4DT
2-03476NB4DT
2-03403NB4DT
2-03752NB4DT
2-03332NB4DT
2-03314NB4DT
2-03309NB4DT
2-03678NB4DT
2-03410NB4DT
2-03460NB4DT
2-03717NB4DT
2-03521NB4DT
2-03674NB4DT
2-03363NB4DT
2-03667NB4DT
2-03475NB4DT
2-03724NB4DT
2-03493NB4DT
2-03617NB4DT
2-03680NB4DT
2-03494NB4DT
2-03450NB4DT
2-03754NB4DT
2-03378NB4DT
2-03712NB4DT
2-03840NB4DT
2-03441NB4DT
2-03416NB4DT
2-03393NB4DT
2-03577NB4DT
2-03751NB4DT
2-03681NB4DT
2-03368NB4DT
2-03333NB4DT
2-03640NB4DT
2-03373NB4DT
2-03358NB4DT
2-03500NB4DT
2-03596NB4DT
2-03811NB4DT
2-03308NB4DT
2-03669NB4DT
2-03337NB4DT
2-03381NB4DT
2-03352NB4DT
2-03488NB4DT
2-03382NB4DT
2-03443NB4DT
2-03357NB4DT
2-03444NB4DT
2-03542NB4DT
2-03599NB4DT
2-03404NB4DT
2-03395NB4DT
2-03365NB4DT
2-03399NB4DT
2-03576NB4DT
2-03458NB4DT
2-03611NB4DT |
| FEI Number |
1526255
|
Recalling Firm/
Manufacturer |
Daavlin Distributing Company
205 W Bement St
Bryan OH 43506-1264
|
| For Additional Information Contact |
800-322-8546 |
|---|
Manufacturer Reason
for Recall | Some of the Calibration/Output Certificates had the outputs reversed. |
|---|
FDA Determined
Cause 2 | Labeling Change Control |
|---|
| Action | An URGENT: MEDICAL DEVICE ADVISORY NOTICE dated 12/11/25 was sent to customers.
Dual calibration allows you to treat at the surface (0 ) of the device or at 9 inches (9 ) away. It has come to our attention that some of the Calibration/Output Certificates had the outputs reversed.
Actions to be taken by the Customer/User:
Talk to your physician regarding treatment plans with the new information listed below.
If you have any questions or concerns, please do not hesitate to contact our office at (800)
322-8546. Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Thank you for your
cooperation. |
|---|
| Quantity in Commerce | 368 units |
|---|
| Distribution | US Nationwide distribution. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FTC
|
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