{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Crawley",
      "state": "N/A",
      "country": "United Kingdom",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82537",
      "recalling_firm": "Elekta Limited",
      "address_1": "Linac House",
      "address_2": "Fleming Way",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin.      Distribution internationally to Denmark, England, Germany, Italy, Netherlands",
      "recall_number": "Z-1297-2019",
      "product_description": "Elekta Unity systems    Product Usage:  Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.",
      "product_quantity": "9 devices",
      "reason_for_recall": "There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.",
      "recall_initiation_date": "20190403",
      "center_classification_date": "20190508",
      "termination_date": "20230501",
      "report_date": "20190515",
      "code_info": "Product Code: UNITY SYSTEM/13553-006/600003, UNITY SYSTEM/10817-011/600010, UNITY SYSTEM/10562-011/600016; UNITY SYSTEM/10719-T03001/600013, UNITY SYSTEM/30004070-001/600023, UNITY SYSTEM/10420-AVL-U/600008, UNITY SYSTEM/11014-UMCU-U/600007, UNITY SYSTEM/11611-40/600011, UNITY SYSTEM/11489-21/600009;      UDI: 1536549, 1536549"
    }
  ]
}