{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Fremont",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65191",
      "recalling_firm": "Optovue, Inc.",
      "address_1": "2800 Bayview Dr",
      "address_2": "N/A",
      "postal_code": "94538-6518",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide and in Canada.",
      "recall_number": "Z-1441-2013",
      "product_description": "Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.    Intended for in vivo imaging.",
      "product_quantity": "~329 users",
      "reason_for_recall": "Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.",
      "recall_initiation_date": "20130514",
      "center_classification_date": "20130531",
      "termination_date": "20131024",
      "report_date": "20130612",
      "code_info": "iVue software version 3.0 and 3.1  3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities."
    }
  ]
}