{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "221311", "product_res_number": "Z-2742-2026", "event_date_initiated": "2026-03-05", "event_date_posted": "2026-07-15", "recall_status": "Open, Classified", "res_event_number": "99331", "product_code": "FTC", "k_numbers": [ "K210881" ], "product_description": "Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders", "code_info": "Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.", "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": "Bob Golding\n419-636-6304 Ext. 215", "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).", "root_cause_description": "Software Design Change", "action": "Daavlin Distributing Company initially notified its consignees about the issue beginning on 3/5/2026 via telephone following with by an email. The firm a follow up URGENT MEDICAL DEVICE Advisory notice on 4/9/2026 with the same information via US mail and email. On 7/10/2026 the firm sent an URGENT MEDICAL DEVICE RECALL notice to all non-responding consignees. The notice explained the issue, potential risk to health, and requested the following: \n\"\" Verify your device is operating ClearLink Controller Software Version 3.17 as follows:\na)\tEnsure your machine is plugged in and on\nb)\tLocate and press the gear icon in the top right corner of the controller screen\nc)\tSelect Machine Info \nd)\tSelect Software Version \ne)\tReview Software Information \n\" Confirm the serial number of your device is 123567890abc. The serial number can be found in all the following places: \n\"\tFor devices that remain in the original packaging, it can be found on the outside of the box\n\"\tFor devices that have been removed from the original packaging, it can be found on the back of your machine centered on the top of the Spine Cover or on the bottom of the Spine Cover \n\"Once you confirm your device is identified as an affected device operating ClearLink Controller Software Version 3.17, contact Daavlin Technical Services immediately (see contact information below). Daavlin will place the device into Fixed Calibration Mode as an interim mitigation until ClearLink Controller Software Version 3.18 can be installed.\n\n\" Complete the enclosed Recall Response Form and return it within 10 business days. \n\nShare this notice with all users of this device.\n\n\" If you distributed the affected device to another facility, immediately provide them with a copy of this notice. \" \nFor questions, please contact: Daavlin Technical Services, Phone: (419) 633-3415, \nEmail: rgolding@phothera.com", "product_quantity": "2 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K812663", "K933952", "K853692", "K220840", "K834493", "K852149", "K840137", "K904427", "K853833", "K050080", "K230382", "K910767", "K864510", "K852579", "K841614", "K233811", "K840132", "K851534", "K843306", "K850660", "K253871", "K242977", "K110912", "K861533", "K883952", "K900649", "K854750", "K861705", "K935524", "K800160", "K842575", "K860347", "K933146", "K853046", "K100378", "K854515", "K860856", "K935572", "K850206", "K864511", "K103540", "K022104", "K854131", "K834491", "K111172", "K851255", "K860566", "K863555", "K864546", "K073066", "K210004", "K833240", "K851859", "K890084", "K812543", "K860932", "K761179", "K072035", "K854004", "K810796", "K811870", "K896831", "K845029", "K853911", "K851858", "K860117", "K063621", "K230076", "K883929", "K862372", "K843814", "K813307", "K132643", "K850204", "K842975", "K852576", "K874889", "K863518", "K850042", "K171702", "K130519", "K872605", "K812579", "K812521", "K853587", "K827890", "K872649", "K050695", "K061589", "K851533", "K134009", "K851535", "K861636", "K864485", "K852534", "K854932", "K760482", "K812225", "K082731", "K924077", "K922963", "K834495", "K041212", "K854707", "K904425", "K850205", "K832794", "K833527", "K192411", "K854111", "K872707", "K851532", "K863937", "K860567", "K872648", "K852290", "K861076", "K022165", "K812446", "K934808", "K150752", "K851408", "K820123", "K860931", "K223882", "K854498", "K924969", "K811586", "K061295", "K872650", "K860198", "K191571", "K853248", "K854224", "K181805", "K935840", "K853545", "K872604", "K853846", "K885026", "K900693", "K871237", "K850493", "K935526", "K870167", "K833524", "K790167", "K860859", "K760471", "K873430", "K040062", "K073503", "K070934", "K242908", "K820492", "K172273", "K852243", "K843647", "K853752", "K844039", "K850203", "K872706", "K860930", "K854020", "K860929", "K860144", "K913760", "K073587", "K800950", "K904426", "K811029", "K861107", "K895410", "K153749", "K021514", "K052660", "K855162", "K020591", "K761186", "K770862", "K862142", "K854154", "K103708", "K860509", "K854170", "K021762", "K854594", "K845028", "K801017", "K885184", "K151795", "K872651", "K840931", "K843902", "K935525", "K200971", "K840133", "K861989", "K925171", "K915426", "K834488", "K896191", "K861447", "K901324", "K853394", "K862263", "K845001", "K761188", "K842384", "K021092", "K244022", "K881385", "K212510", "K210881", "K882722", "K862341", "K103204", "K834492", "K854171", "K852957", "K862097", "K933953", "K852684", "K250425", "K811585", "K860370", "K885025", "K852053", "K930856", "K833490", "K761187", "K840158", "K933954", "K111049", "K173436", "K192642", "K202827", "K982082", "K851536", "K853177", "K881923", "K852348", "K862608", "K904428", "K761189", "K150912", "K842787", "K853679", "K810476", "K011197", "K833350", "K033946", "K051330", "K182215", "K860489", "K885029", "K024020", "K254234", "K864907", "K803264", "K861963", "K833511", "K861570", "K792500", "K042502", "K170489", "K090097", "K091568", "K844870", "K810688", "K031800", "K191086" ], "registration_number": [ "3045522560", "9680413", "1318319", "3008393409", "1526255", "3014226003", "3004167969", "3004374705", "3004193926", "3015060197", "3013229265", "3006580954", "3007699081", "3008255748", "3008872264", "3017406171", "1022129", "1528161", "3003882673", "3023306694", "3036425107", "3002672225", "3009736547", "3005205318", "3016746323", "3011024620" ], "fei_number": [ "3045522560", "1000122747", "1318319", "3008393409", "1526255", "3014226003", "3004167969", "3004374705", "3004193926", "3015060197", "3013229265", "3004531930", "3006580954", "3007699081", "3008255748", "3008872264", "3017406171", "1022129", "3003882673", "3023306694", "3036425107", "3002672225", "3009736547", "3005205318", "3016746323", "3011024620" ], "device_name": "Light, Ultraviolet, Dermatological", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4630", "device_class": "2" } } ] }