{ "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": 1 } }, "results": [ { "cfres_id": "130886", "product_res_number": "Z-0224-2015", "event_date_initiated": "2012-10-24", "event_date_posted": "2014-11-17", "recall_status": "Terminated", "event_date_terminated": "2014-11-17", "res_event_number": "69537", "product_code": "HQF", "k_numbers": [ "K110228" ], "product_description": "Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20.\nOpthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.", "code_info": "Model MC-500 Serial numbers:  50277 50310 50330 50331 50357 50358 50383 50408 50417 50418 50425 50426 50439 50440 50445 50446 50471 50514 50311 50359 50382,", "firm_fei_number": "2936921", "recalling_firm": "Nidek Inc", "address_1": "47651 Westinghouse Dr", "city": "Fremont", "state": "CA", "postal_code": "94539-7474", "additional_info_contact": "Neo Yamaguchi\n510-353-7785", "reason_for_recall": "When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program.", "root_cause_description": "Device Design", "action": "Nidek Field Service engineers visited each affected location to upgrade software.", "product_quantity": "21affected devices", "distribution_pattern": "US Distribution in the states of: NJ, SC, IL, MI, NY, CA, TX, OH, IN, UT, and MN.", "openfda": { "k_number": [ "K860358", "K781965", "K834060", "K063297", "K103056", "K190448", "K832089", "K142398", "K061024", "K092621", "K170302", "K833274", "K952894", "K840854", "K201502", "K841856", "K201623", "K862987", "K893709", "K040209", "K091981", "K212630", "K123056", "K251772", "K833532", "K842412", "K990075", "K812219", "K021538", "K883213", "K043613", "K192045", "K854949", "K252979", "K960522", "K890086", "K080423", "K832316", "K926470", "K910532", "K170067", "K081774", "K220877", "K100019", "K220430", "K031665", "K203130", "K842250", "K033941", "K844358", "K020374", "K951079", "K960971", "K903421", "K062074", "K910612", "K973193", "K862568", "K121187", "K223132", "K123542", "K213592", "K852529", "K894835", "K875000", "K090774", "K031023", "K925663", "K863246", "K043236", "K130195", "K813492", "K840145", "K854288", "K140362", "K964751", "K051944", "K791659", "K091581", "K152603", "K081565", "K972514", "K103547", "K904699", "K133358", "K062624", "K231011", "K120825", "K001772", "K081946", "K140336", "K870839", "K932296", "K872846", "K864063", "K932836", "K112154", "K122202", "K782106", "K142830", "K885164", "K910805", "K842251", "K111460", "K833533", "K904366", "K013760", "K023094", "K190083", "K931784", "K050541", "K905453", "K180402", "K091534", "K100253", "K852464", "K202760", "K935747", "K900199", "K070776", "K895213", "K222157", "K222395", "K243014", "K990665", "K152688", "K833232", "K850572", "K230722", "K843965", "K853890", "K844357", "K905141", "K242397", "K881134", "K131207", "K091064", "K942180", "K882372", "K230350", "K834305", "K130933", "K220974", "K844668", "K881494", "K852234", "K971950", "K240615", "K863591", "K010372", "K111108", "K882908", "K834610", "K111643", "K893630", "K124043", "K895196", "K050807", "K782065", "K232051", "K890509", "K981196", "K841855", "K041598", "K894273", "K233911", "K873460", "K142172", "K232417", "K153769", "K181682", "K840590", "K133019", "K801336", "K973220", "K072823", "K171488", "K230228", "K251507", "K874609" ], "pma_number": [ "P990078" ], "registration_number": [ "3005350457", "2939653", "3009026057", "9680671", "3013515803", "3038356864", "1211998", "8030392", "2028159", "3004858034", "1650907", "3005012805", "9681121", "2247224", "3008156177", "3002808022", "3030860039", "8030988", "1222616", "3020611964", "3004497289", "3004467263", "3009298127", "3045817901", "3002807715", "3005941719", "1932180", "3001592626", "1920664", "3027683457", "9615745", "3015658550", "3007589150", "3010220595", "3012037425", "3016678045", "1054713", "3008252121", "2246552", "2529392", "3010849408", "1000391004", "3009337401", "3010487482", "2936921", "1047843", "3002807090", "3009462521", "1644019", "8043792", "3029221947", "9615030", "1018470", "3016405041", "3007851054", "3002991496", "1526711", "1928237", "2031962", "1313525", "3010208880", "9611516" ], "fei_number": [ "1000119305", "3005350457", "2939653", "3009026057", "3038356864", "1211998", "3004858034", "3005012805", "3002806902", "1000120916", "3030860039", "3002808022", "3002681132", "3002806863", "3004497289", "3004467263", "1317628", "3009298127", "3045817901", "3003282815", "1000121498", "3002807715", "3001592626", "3002807944", "1920664", "3027683457", "1000122089", "3003465293", "3015658550", "3007589150", "3002445546", "3002807111", "3010220595", "3012037425", "3003559308", "3008252121", "3000314405", "3016678045", "1720381", "1000125771", "2246552", "3010849408", "1000391004", "3009337401", "3010487482", "2936921", "1047843", "1000117501", "3009462521", "3029221947", "1018470", "3016405041", "3007851054", "3002991496", "1526711", "1928237", "3001362763", "3006003617", "3002808269", "1000114111", "3010208880" ], "device_name": "Laser, Ophthalmic", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.4390", "device_class": "2" } } ] }