{
  "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": [
    {
      "status": "Terminated",
      "city": "Feldkirchen",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72804",
      "recalling_firm": "Brainlab AG",
      "address_1": "Kapellenstr. 12",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.",
      "recall_number": "Z-0647-2016",
      "product_description": "RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms",
      "product_quantity": "20 systems",
      "reason_for_recall": "Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.",
      "recall_initiation_date": "20151105",
      "center_classification_date": "20160114",
      "termination_date": "20170821",
      "report_date": "20160120",
      "code_info": "Brain Metastases version 1.0.0    Model/catalogue number       Description  21702-04                     ELEMENTS AUT. BRAIN METASTASES PLAN INST  21703-01                     ELEMENTS ADAPT HYB SURG ANALYSIS LICENSE  21703-02                     ELEMENTS ADAPT HYB SURG ANALYSIS INST  21702                       ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-12                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-36                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21702-60                     ELEMENTS AUTOMATIC BRAIN METS PLAN SUB  21703                       ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-12                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-36                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21703-60                     ELEMENTS AD-HYBRID SURG ANALYSIS SUBSCR  21713                       ELEMENTS ADAPTIVE HYBRID SURG. ANALYSIS  21722                       ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-12                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-36                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21722-60                     ELEMENTS AUTO. BRAIN MET PLAN SUBS. FOC  21723                       ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-12                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-36                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21723-60                     ELEMENTS ADAPT HYB SURG ANALYS SUBS. FOC  21732                       ELEMENTS AUTOMATIC BRAIN METS PLAN. 12M"
    }
  ]
}