{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 15 } }, "results": [ { "cfres_id": "193083", "product_res_number": "Z-1073-2022", "event_date_initiated": "2022-04-26", "event_date_created": "2022-05-12", "recall_status": "Open, Classified", "res_event_number": "89990", "product_code": "FTC", "k_numbers": [ "K100378" ], "product_description": "1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], \n[1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]", "code_info": "UDI-DI: +B2809806OS0004CX60K, +B2809807OS0004CX50K, +B2809807OS0004CX60L, +B2809807OS0400CX60L, and +B2809807OS0400CX6A10W. Serial Numbers: OS22183PLNBCX0004, OS22320PLNBCX0004, OS23725PLNBCX0004, OS24083PLNBCX0004, OS24089PLNBCX0004, OS24090PLNBCX0004, OS23532PLA1CX0400, OS22097PLNBCX0004, OS22200PLNBCX0004, OS22265PLNBCX0004, OS22270PLNBCX0004, OS22304PLNBCX0004, OS22739PLNBCX0004, OS22788PLNBCX0004, OS22795PLNBCX0004, OS23239PLNBCX0004, OS23609PLNBCX0004, OS23894PLNBCX0004, OS24017PLNBCX0004, OS24254PLNBCX0004, OS24810PLNBCX0004, OS21997PLNBCX0004, OS22060PLNBCX0004, OS22063PLNBCX0004, OS22273PLNBCX0004, OS22309PLNBCX0004, OS22637PLNBCX0004, OS22680PLNBCX0004, OS22736PLNBCX0004, OS22738PLNBCX0004, OS22770PLNBCX0004, OS22789PLNBCX0004, OS22796PLNBCX0004, OS22919PLNBCX0004, OS22977PLNBCX0004, OS22980PLNBCX0004, OS22983PLNBCX0004, OS23244PLNBCX0004, OS23252PLNBCX0004, OS23440PLNBCX0004, OS23681PLNBCX0004, OS23724PLNBCX0004, OS23762PLNBCX0004, OS23855PLNBCX0004, OS23856PLNBCX0004, OS24008PLNBCX0004, OS24077PLNBCX0004, OS24104PLNBCX0004, OS24107PLNBCX0004, OS24109PLNBCX0004, OS24113PLACX0400, OS24127PLNBCX0004, OS24308PLNBCX0004, OS24310PLNBCX0004, OS24376PLNBCX0004, OS24467PLNBCX0004, OS24478PLNBCX0004, OS24229PLACX0400, OS22663PLNBCX0004, OS23940PLNBCX0004, OS23461PLNBCX0004, OS24829PLNBCX0004, OS22154PLNBCX0004, OS22112PLNBCX0004, OS22537PLNBCX0004, OS22271PLNBCX0004, OS24078PLNBCX0004, OS22227PLNBCX0004, OS23274PLNBCX0004, OS23481PLNBCX0004, OS23525PLNBCX0004, OS23676PLNBCX0004, OS23711PLNBCX0004, OS23910PLNBCX0004, OS24296PLNBCX0004, OS24325PLNBCX0004, OS24345PLNBCX0004, OS24358PLNBCX0004, OS24828PLNBCX0004, OS22794PLNBCX0004, OS24479PLNBCX0004, OS24682PLNBCX0004, OS24760PLNBCX0004, OS24228PLNBCX0004, OS24857PLNBCX0004, OS22033PLNBCX0004, OS22293PLNBCX0004, OS23526PLNBCX0004, OS23866PLNBCX0004, OS23896PLNBCX0004, OS24500PLNBCX0004, OS22439PLNBCX0004, OS22641PLNBCX0004, OS22766PLNBCX0004, OS23502PLNBCX0004, OS23941PLNBCX0004, OS24110PLNBCX0004, OS22015PLNBCX0004, OS22452PLNBCX0004, OS22453PLNBCX0004, OS24020PLNBCX0004, OS24680PLNBCX0004, OS22090PLNBCX0004, OS22266PLNBCX0004, OS22442PLNBCX0004, OS22633PLNBCX0004, OS22640PLNBCX0004, OS22764PLNBCX0004, OS23233PLNBCX0004, OS23255PLNBCX0004, OS23496PLNBCX0004, OS23527PLNBCX0004, OS23528PLNBCX0004, OS23873PLNBCX0004, OS23911PLNBCX0004, OS23961PLNBCX0004, OS24082PLNBCX0004, OS24105PLNBCX0004, OS24132PLNBCX0004, OS24211PLNBCX0004, OS22716PLACX0400, OS22717PLBBCX0004, OS23353PLACX0400, OS23354PLACX0400, OS23352PLACX0400, OS23355PLBBCX0004, OS22103PLACX0400, OS22062PLNBCX0004, OS22258PLNBCX0004, OS22229PLNBCX0004, OS22818PLNBCX0004, OS22869PLA1CX0400, OS23253PLNBCX0004, OS24051PLNBCX0004, OS24281PLNBCX0004, OS24422PLNBCX0004, OS24423PLNBCX0004, OS23183PLNBCX0004, OS22013PLNBCX0004, OS22049PLNBCX0004, OS22075PLNBCX0004, OS22088PLNBCX0004, OS22092PLNBCX0004, OS22106PLNBCX0004, OS22263PLNBCX0004, OS22269PLNBCX0004, OS22308PLNBCX0004, OS22397PLNBCX0004, OS22440PLNBCX0004, OS22441PLNBCX0004, OS22502PLA1CX0400, OS22635PLNBCX0004, OS22643PLNBCX0004, OS22681PLNBCX0004, OS22741PLNBCX0004, OS22762PLNBCX0004, OS22763PLNBCX0004, OS22765PLNBCX0004, OS22769PLNBCX0004, OS22791PLNBCX0004, OS22812PLNBCX0004, OS22822PLNBCX0004, OS22917PLNBCX0004, OS22918PLNBCX0004, OS23049PLNBCX0004, OS23053PLNBCX0004, OS23061PLNBCX0004, OS23101PLNBCX0004, OS23237PLNBCX0004, OS23240PLNBCX0004, OS23241PLNBCX0004, OS23243PLNBCX0004, OS23246PLNBCX0004, OS23254PLNBCX0004, OS23272PLNBCX0004, OS23418PLNBCX0004, OS23463PLNBCX0004, OS23466PLNBCX0004, OS23470PLNBCX0004, OS23474PLA1CX0400, OS23480PLNBCX0004, OS23529PLNBCX0004, OS23530PLNBCX0004, OS23569PLNBCX0004, OS23620PLNBCX0004, OS23675PLNBCX0004, OS23756PLNBCX0004, OS23857PLNBCX0004, OS23867PLNBCX0004, OS23890PLNBCX0004, OS23898PLNBCX0004, OS23909PLNBCX0004, OS24106PLNBCX0004, OS24166PLNBCX0004, OS24168PLA1CX0400, OS24227PLNBCX0004, OS24312PLNBCX0004, OS24539PLNBCX0004, OS24630PLNBCX0004, OS24743PLNBCX0004, OS24789PLNBCX0004, OS24791PLNBCX0004, OS24811PLNBCX0004, OS23940PLNBCX0004, OS22777PLNBCX0004, OS22778PLNBCX0004, OS20337PLNBCX0004, OS22201PLNBCX0004, OS22303PLNBCX0004, OS22334PLNBCX0004, OS22612PLNBCX0004, OS22871PLNBCX0004, OS22873PLNBCX0004, OS23086PLNBCX0004, OS23189PLNBCX0004, OS24421PLNBCX0004.", "firm_fei_number": "1526255", "recalling_firm": "Daavlin Distributing Company", "address_1": "205 W Bement St", "city": "Bryan", "state": "OH", "postal_code": "43506-1264", "additional_info_contact": "800-322-8546", "reason_for_recall": "Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0\" inches to \"9. Resulting in over or under dosing.", "root_cause_description": "Software Design Change", "action": "Beginning April 26, 2022 Daavlin Distributing Co. is sent a recall notification letter via certified mail to customers. Customers are to acknowledge receipt of the notification and a company representative will call customers to arrange for return of the devices to update software. If you have any questions or concerns, contact the company at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, EST.", "product_quantity": "216", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI, WV and the countries of Australia, Canada.", "openfda": { "k_number": [ "K852684", "K863555", "K913760", "K852579", "K111172", "K854498", "K761187", "K904426", "K850042", "K854131", "K820492", "K812579", "K843306", "K853833", "K844870", "K872707", "K860930", "K050080", "K885026", "K803264", "K924969", "K811870", "K860929", "K151795", "K073066", "K851534", "K182215", "K827890", "K181805", "K031800", "K103204", "K834492", "K134009", "K834491", "K854515", "K853679", "K770862", "K021514", "K861533", "K022165", "K250425", "K872648", "K860856", "K052660", "K861636", "K853752", "K933146", "K853846", "K930856", "K861570", "K851859", "K852243", "K851255", "K024020", "K844039", "K873430", "K933953", "K935524", "K202827", "K933954", "K852290", "K982082", "K850205", "K860370", "K130519", "K862097", "K904428", "K854224", "K852053", "K883952", "K853177", "K761189", "K861076", "K790167", "K833511", "K801017", "K812521", "K854020", "K761186", "K170489", "K761179", "K843647", "K933952", "K885025", "K021762", "K842384", "K192642", "K233811", "K852957", "K872651", "K220840", "K864907", "K885184", "K810476", "K851535", "K841614", "K934808", "K800950", "K760471", "K922963", "K811586", "K853394", "K760482", "K020591", "K853587", "K874889", "K103708", "K843814", "K900649", "K850203", "K860198", "K200971", "K253871", "K852576", "K173436", "K833524", "K883929", "K860509", "K103540", "K850204", "K853545", "K855162", "K860931", "K230382", "K860566", "K171702", "K840158", "K834495", "K863518", "K924077", "K863937", "K812543", "K854171", "K810688", "K860859", "K812446", "K845028", "K861963", "K861447", "K022104", "K885029", "K896831", "K861989", "K862263", "K153749", "K041212", "K853046", "K864485", "K851533", "K935526", "K820123", "K854170", "K800160", "K842787", "K890084", "K833350", "K872605", "K111049", "K210004", "K842575", "K900693", "K860347", "K871237", "K904427", "K100378", "K833490", "K244022", "K842975", "K850206", "K850660", "K091568", "K033946", "K212510", "K853248", "K904425", "K861107", "K881923", "K132643", "K864510", "K851408", "K812225", "K792500", "K150752", "K895410", "K150912", "K191571", "K910767", "K840931", "K070934", "K851532", "K864546", "K082731", "K172273", "K254234", "K854707", "K090097", "K832794", "K042502", "K845029", "K862341", "K191086", "K854004", "K854154", "K901324", "K854750", "K935840", "K896191", "K812663", "K860117", "K862372", "K242977", "K860489", "K061295", "K011197", "K834488", "K851536", "K854111", "K853911", "K813307", "K051330", "K040062", "K840132", "K850493", "K882722", "K860932", "K811585", "K851858", "K935525", "K935572", "K840133", "K050695", "K242908", "K852534", "K230076", "K852348", "K834493", "K810796", "K843902", "K862142", "K210881", "K860144", "K870167", "K854594", "K872650", "K072035", "K853692", "K063621", "K881385", "K862608", "K925171", "K852149", "K840137", "K061589", "K223882", "K845001", "K761188", "K833527", "K833240", "K073503", "K192411", "K864511", "K073587", "K811029", "K872706", "K854932", "K021092", "K861705", "K915426", "K860567", "K872649", "K110912", "K872604" ], "registration_number": [ "3004193926", "3016746323", "3003882673", "3008872264", "3005205318", "3008255748", "3045522560", "3002672225", "3006580954", "3014226003", "3008393409", "3036425107", "3007699081", "3004167969", "1318319", "3023306694", "9680413", "3013229265", "3015060197", "3011024620", "3009736547", "3004374705", "1528161", "1526255", "1022129", "3017406171" ], "fei_number": [ "3004193926", "3016746323", "3003882673", "3008872264", "3005205318", "3008255748", "3045522560", "3002672225", "3006580954", "3014226003", "3008393409", "3036425107", "3007699081", "3004167969", "1318319", "3023306694", "3013229265", "3015060197", "3011024620", "1000122747", "3009736547", "3004374705", "1526255", "1022129", "3004531930", "3017406171" ], "device_name": "Light, Ultraviolet, Dermatological", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4630", "device_class": "2" } } ] }