{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "172309",
      "product_res_number": "Z-1412-2019",
      "event_date_initiated": "2018-06-27",
      "event_date_created": "2019-05-23",
      "recall_status": "Open, Classified",
      "res_event_number": "82662",
      "product_code": "IWB",
      "k_numbers": [
        "K173791"
      ],
      "product_description": "Leksell GammaPlan 11.1\n\nProduct Usage:\nLeksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.",
      "code_info": "Software Version 11.1",
      "firm_fei_number": "3002806883",
      "recalling_firm": "Elekta Instrument AB",
      "address_1": "Kungstensgatan 18 18 kungstensgatan",
      "city": "Stockholm",
      "country": "Sweden",
      "reason_for_recall": "The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.",
      "root_cause_description": "Software design",
      "action": "Elekta initially notified customers on about 06/27/2018 via \"URGENT IMPORTANT FIELD SAFETY NOTIFICATION\" LETTER.  Instructions included to post the recall notice in a place accessible to all users, e.g. Instructions for Use, until the recall action is closed, advise the appropriate personnel working with the affected device of the recall and the content of the recall notification letter, and complete and return the Acknowledgement Form.  \n\nElekta updated their recall strategy on about 11/21/2018 and will be providing all affected customers with software upgrade 11.1.1.  Electa service engineers will be pro-actively reaching out to customers to organize a date for installation on all affected devices.  An updated recall notification was not sent to customers.",
      "product_quantity": "52 devices",
      "distribution_pattern": "Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA.\n\nInternational distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.",
      "openfda": {
        "k_number": [
          "K053485",
          "K063512",
          "K964606",
          "K863180",
          "K151159",
          "K061540",
          "K250391",
          "K051022",
          "K912250",
          "K000478",
          "K827583",
          "K203146",
          "K960892",
          "K984563",
          "K173789",
          "K871215",
          "K131777",
          "K203250",
          "K001006",
          "K780948",
          "K984328",
          "K180571",
          "K133565",
          "K924849",
          "K850543",
          "K142219",
          "K061941",
          "K102533",
          "K914808",
          "K222047",
          "K925133",
          "K041125",
          "K970647",
          "K860849",
          "K983917",
          "K200050",
          "K973441",
          "K150191",
          "K151561",
          "K160440",
          "K092083",
          "K120811",
          "K060314",
          "K190844",
          "K172706",
          "K894165",
          "K232854",
          "K173791"
        ],
        "registration_number": [
          "3015232217",
          "3006946288",
          "3015620182",
          "2939248",
          "3020999824",
          "3005136058",
          "1038814",
          "9617016",
          "3015621321",
          "3014273653"
        ],
        "fei_number": [
          "3015232217",
          "3006946288",
          "3015620182",
          "2939248",
          "3020999824",
          "3005136058",
          "1038814",
          "3002806900",
          "3015621321",
          "3014273653"
        ],
        "device_name": "System, Radiation Therapy, Radionuclide",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5750",
        "device_class": "2"
      }
    }
  ]
}