{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "104480",
      "product_res_number": "Z-0312-2012",
      "event_date_initiated": "2011-05-26",
      "event_date_posted": "2011-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-10-06",
      "res_event_number": "60128",
      "product_code": "IWB",
      "k_numbers": [
        "K984328"
      ],
      "product_description": "Elekta Leksell Gamma Knife C 1.2, 4 and 4C\n\n\nProduct Usage:  Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.",
      "code_info": "4339, 4349, 5026, 4326, 5034, 4346, 4158, 4307, 4337, 4327, 4340, 5023, 5035, 5036,  4329, 4306, 4365, 4357, 5022, 4363, 4354, 4302, 4333, 4309, 4366, 4351, 4342, 4315, 4352, 4353, 4328, 5000, 4314, 4338, 4303, 4207, 4332, 4322, 4343, 4321, 4334, 4358",
      "firm_fei_number": "1037831",
      "recalling_firm": "Elekta, Inc.",
      "address_1": "4775 Peachtree Industrial Blvd",
      "address_2": "Bldg 300 #300",
      "city": "Norcross",
      "state": "GA",
      "postal_code": "30092-3011",
      "additional_info_contact": "Thoma Valentine\n770-670-2548",
      "reason_for_recall": "Several of the LMR03 actuators with bronze drive nut have failed unexpectedly, creating a potential safety hazard for the operator and patient.",
      "root_cause_description": "Pending",
      "action": "Elekta sent an IMPORTANT NOTICE: Urgent Field Safety Notice letter dated May 12, 2011 to affected customers. The notice identified the affected product, problem, and actions to be taken by the user. The letter describes special care to be used in operating the helmet changer actuator LMR03.  The letter states that Elekta will replace all actuators LMRO3.   For more details contact your local Elekta representative.\n.",
      "product_quantity": "44",
      "distribution_pattern": "Nationwide Distribution (USA) - including the states of: CA, CO,  DAL, FL, GA, IL, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI and Puerto Rico",
      "openfda": {
        "k_number": [
          "K051022",
          "K160440",
          "K001006",
          "K970647",
          "K871215",
          "K142219",
          "K180571",
          "K984563",
          "K000478",
          "K925133",
          "K250391",
          "K860849",
          "K983917",
          "K222047",
          "K173789",
          "K041125",
          "K190844",
          "K780948",
          "K120811",
          "K912250",
          "K973441",
          "K092083",
          "K914808",
          "K151159",
          "K151561",
          "K203250",
          "K894165",
          "K053485",
          "K061540",
          "K200050",
          "K150191",
          "K102533",
          "K924849",
          "K061941",
          "K133565",
          "K203146",
          "K232854",
          "K063512",
          "K131777",
          "K173791",
          "K172706",
          "K984328",
          "K850543",
          "K863180",
          "K827583",
          "K964606",
          "K060314",
          "K960892"
        ],
        "registration_number": [
          "3015232217",
          "3015621321",
          "3014273653",
          "1038814",
          "9617016",
          "3006946288",
          "2939248",
          "3020999824",
          "3005136058",
          "3015620182"
        ],
        "fei_number": [
          "3015232217",
          "3002806900",
          "3015621321",
          "3014273653",
          "1038814",
          "3006946288",
          "2939248",
          "3020999824",
          "3005136058",
          "3015620182"
        ],
        "device_name": "System, Radiation Therapy, Radionuclide",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5750",
        "device_class": "2"
      }
    }
  ]
}