{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "131530",
      "product_res_number": "Z-0588-2015",
      "event_date_initiated": "2014-11-10",
      "event_date_posted": "2014-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-03-18",
      "res_event_number": "69778",
      "product_code": "LHN",
      "k_numbers": [
        "K120676"
      ],
      "product_description": "MEVION S250, used for proton radiation therapy.",
      "code_info": "Serial Number: S250-0001",
      "firm_fei_number": "3007087027",
      "recalling_firm": "Mevion Medical Systems, Inc.",
      "address_1": "300 Foster St",
      "city": "Littleton",
      "state": "MA",
      "postal_code": "01460-2017",
      "additional_info_contact": "Thomas H. Faris\n978-540-1500",
      "reason_for_recall": "Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction.  This could result in an incorrect dose delivery of no more than 5%.",
      "root_cause_description": "Software design",
      "action": "Mevion Medical Systems sent an Important Safety Notice letter to the affected customer.  The letter identified the affected product, problem and actions to be taken.  A software update addressing the issue will be provided to the customer on or about December 5, 2014.\n\nFor questions or concerns, email lbouchet@mevion.com\nor call 978-540-1555.",
      "product_quantity": "1",
      "distribution_pattern": "US Distribution in the state of MO",
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        "device_name": "System, Radiation Therapy, Charged-Particle, Medical",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5050",
        "device_class": "2"
      }
    }
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}