{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "104476",
      "product_res_number": "Z-0307-2012",
      "event_date_initiated": "2011-06-23",
      "event_date_posted": "2011-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-01-31",
      "res_event_number": "60125",
      "product_code": "IWB",
      "k_numbers": [
        "K973441"
      ],
      "product_description": "Elekta Leksell Gamma Plan\n\nProduct Usage:  Gamma Plan is a computer based system designed for Gamma Knife treatment planning.",
      "code_info": "6107 and 6115",
      "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": "Thomas Valentine\n770-670-2548",
      "reason_for_recall": "There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.",
      "root_cause_description": "Labeling False and Misleading",
      "action": "Elekta sent an IMPORTANT NOTICE letter dated  June 23, 2011 to affected customers.  The notice identified the product, problem, and corrective actions to be taken by the user.  The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released.  For questions contact your local Elekta representative.",
      "product_quantity": "2",
      "distribution_pattern": "Nationwide Distribution (USA) - including the states of: NM and WA",
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        "device_name": "System, Radiation Therapy, Radionuclide",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5750",
        "device_class": "2"
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}