{ "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": 21 } }, "results": [ { "cfres_id": "130878", "product_res_number": "Z-0222-2015", "event_date_initiated": "2013-05-24", "event_date_posted": "2014-11-17", "recall_status": "Terminated", "event_date_terminated": "2014-11-17", "res_event_number": "69531", "product_code": "HQF", "k_numbers": [ "K110228" ], "product_description": "MC-500 Multicolor Laser Photocoagulator using software version 2.20.\nOpthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.", "code_info": "MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609", "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": "Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.", "root_cause_description": "Software design", "action": "Nidek Engineers visited all affected sites to install new software version.\nFor questions regarding this recall call 510-353-7785.", "product_quantity": "5", "distribution_pattern": "US Distribution in the states of: CA, NE, and NY.", "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", 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