{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177217",
      "product_res_number": "Z-0771-2020",
      "event_date_initiated": "2019-02-25",
      "event_date_created": "2020-01-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-06-15",
      "res_event_number": "84112",
      "product_code": "NQE",
      "k_numbers": [
        "K130565",
        "K151706",
        "K173980"
      ],
      "product_description": "NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.",
      "code_info": "Serial numbers 120080, 120081, 120086, 120087, 120088, 120090, 120091, 120092, 120093, 120094, 120095, 120096, and 170001.",
      "firm_fei_number": "2936921",
      "recalling_firm": "Nidek, Inc.",
      "address_1": "47651 Westinghouse Dr",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94539-7474",
      "additional_info_contact": "Mr. Todd Milholland\n800-223-9044",
      "reason_for_recall": "The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)",
      "root_cause_description": "Device Design",
      "action": "The recalling firm issued letters dated 2/7/2019 via FedEx explaining the issue, informing the consignee there was no risk associated with use of the device, and that the firm is preparing for the replacement parts in order to schedule for the correction to be made.",
      "product_quantity": "13 devices",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, IL, KS, MD, NJ, NY, PA, SC, and VA, as well as PR.",
      "openfda": {
        "k_number": [
          "K120264",
          "K130565",
          "K151706",
          "K191558",
          "K142417",
          "K040373",
          "K171313",
          "K062763",
          "K173980"
        ],
        "registration_number": [
          "3002807715",
          "9680854",
          "2936921",
          "2242863",
          "3008717264",
          "9614661",
          "8030392",
          "3008729548",
          "9614730",
          "1054713"
        ],
        "fei_number": [
          "3002807715",
          "3002680900",
          "2936921",
          "2242863",
          "3008717264",
          "3008729548",
          "1000494121",
          "1000114111",
          "1000175127"
        ],
        "device_name": "Microscope, Specular",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1850",
        "device_class": "2"
      }
    }
  ]
}