{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Atlanta",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97705",
      "recalling_firm": "Elekta, Inc.",
      "address_1": "400 Perimeter Center Ter NE Ste 50",
      "address_2": "N/A",
      "postal_code": "30346-1227",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AR, CA, CO, FL, ID, IL, LA, MA, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI, and WV. The countries of  Algeria, Australia, Austria, Belgium, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Kuwait, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.",
      "recall_number": "Z-0433-2026",
      "product_description": "Brand Name: Leksell Stereotactic System  Product Name: Leksell Vantage Stereotactic System  Software Version: n/a  Product Description: The Intended Purpose of Leksell¿ Vantage\" Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.",
      "product_quantity": "338",
      "reason_for_recall": "Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound",
      "recall_initiation_date": "20250930",
      "center_classification_date": "20251105",
      "report_date": "20251112",
      "code_info": "Lot Code: UDI References: Arc: 07340048304856  Support Arc: 07340048304849  Arcs and Support Arcs with Serial Numbers: SH00001-SH00338",
      "more_code_info": ""
    }
  ]
}