{
  "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": "Atlanta",
      "address_1": "400 Perimeter Center Ter NE Ste 50",
      "reason_for_recall": "If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing maintenance on the X-ray generator.",
      "address_2": "",
      "product_quantity": "2",
      "code_info": "Serial Numbers 6018, 6047, 6090, 6094, 6171, 8018",
      "center_classification_date": "20170707",
      "distribution_pattern": "US Distribution to the states of  : NY and PA.",
      "state": "GA",
      "product_description": "Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, orbital tumors, ocular tumors, optic nerve tumors, benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas), skull base tumors, head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal  tumors, arteriovenous malformations, cavernous malformations, skull base tumors).",
      "report_date": "20170719",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Elekta, Inc.",
      "recall_number": "Z-2697-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77291",
      "termination_date": "20171018",
      "more_code_info": "",
      "recall_initiation_date": "20170523",
      "postal_code": "30346-1227",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}