{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "130780",
      "product_res_number": "Z-0223-2015",
      "event_date_initiated": "2012-08-06",
      "event_date_posted": "2014-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-11-17",
      "res_event_number": "69508",
      "product_code": "LZS",
      "pma_numbers": [
        "P970053"
      ],
      "product_description": "Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII.\nOpthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.",
      "code_info": "Serial numbers: 530054 530055 530070 530073 530078 530082 530086 530087 530098 530106 530121 530123 530150 530155",
      "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": "Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.",
      "root_cause_description": "Component design/selection",
      "action": "Nidek Engineers visited each site to perform correction - fuse holders have been inspected and replaced if necessary.\n\nAn Engineering Change Order was issued on June 1, 2012,  for inspection and/or replacement of affected fuse holders by Nidek Service Engineers.\n\nFor further questions please call (510) 353-7785.",
      "product_quantity": "14 units",
      "distribution_pattern": "US Distribution including the states of CO, NY, MO, LA, ME, CA, MI, AZ, CT and FL.",
      "openfda": {
        "pma_number": [
          "P970056",
          "P990027",
          "P990010",
          "P910067",
          "P030008",
          "P960019",
          "P970005",
          "P020050",
          "P970043",
          "P060004",
          "P910062",
          "P970053",
          "P930016",
          "P980008",
          "P930034"
        ],
        "registration_number": [
          "3002807715",
          "9615030",
          "3006695864",
          "9710340",
          "3007606649",
          "1920664",
          "2936921",
          "3012236936",
          "3003288808",
          "3038356864",
          "8030392"
        ],
        "fei_number": [
          "3002807715",
          "3006695864",
          "3002483854",
          "1920664",
          "2936921",
          "3012236936",
          "3003288808",
          "3038356864",
          "3001362763",
          "3003691824"
        ],
        "device_name": "Excimer Laser System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}