{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fremont",
      "address_1": "47651 Westinghouse Dr",
      "reason_for_recall": "During treatment planning, the procedure was programmed with an unintended (wrong) correction.",
      "address_2": "",
      "product_quantity": "29",
      "code_info": "Software version 1.11 and 1.12.  Serial numbers of Affected devices:  MNE0009;  NVE0002;  OH00295;  NC00185;  CAE0016;  COE0008;  MI00131;  GA00241;  CAE0007;  VAE0004;  MI00131;  CAE0031;  AZ00167;  COE0011;  CA00561;  PAE0003;  TN00168;  MNE0009;  WA00246;  CAE0047;  OHE0005;  WAE0008;  MI00244;  NY00473;  CAE0007;  WAE0008;  NVE0002;  WA00233;  CAE0016.",
      "center_classification_date": "20170320",
      "distribution_pattern": "Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.",
      "state": "CA",
      "product_description": "Final Fit Software Version 1.11 and  1.12;  PC Based software installed outside Nidek EC-5000 Excimer Laser System.      Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of 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.",
      "report_date": "20170329",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Nidek Inc",
      "recall_number": "Z-1494-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76376",
      "termination_date": "20171205",
      "more_code_info": "",
      "recall_initiation_date": "20170201",
      "postal_code": "94539-7474",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}