{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "131533",
      "product_res_number": "Z-0836-2015",
      "event_date_initiated": "2014-11-07",
      "event_date_posted": "2014-12-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-06-29",
      "res_event_number": "69781",
      "product_code": "LHN",
      "k_numbers": [
        "K132847"
      ],
      "product_description": "adaPT insight (12C),  v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.",
      "code_info": "PAT.109 (US), Treatment room 4",
      "firm_fei_number": "3000256071",
      "recalling_firm": "Ion Beam Applications S.A.",
      "address_1": "Chemin du Cyclotron, 3 3 chemin du cyclotron",
      "city": "Louvain La Neuve",
      "country": "Belgium",
      "reason_for_recall": "Two issues were identified:\n\n1.   In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a  wrong  geometrical  calibration   file,  resulting  in  an  alignment offset  for this  specific  mode  of acquisition.\n2.   A gantry collision  incident required  the IBA service team to verify the gantry alignment and protons  I x-ray  beams  colinearity, du",
      "root_cause_description": "Software design (manufacturing process)",
      "action": "The firm, IBA, sent a \" User Notice\" dated November 7, 2014, to the sole affected site-UPHS Customer. The notice describes the product, problem and actions to be taken. The customer was instructed that the KV/kV source acquisition mode has been disabled and shall not be used for patient alignment until system is officially confirmed to be back within tolerances.\n\nIBA will change the kV/kV Single Source acquisition workflow configuration file to be linked to the correct geometrical calibration file and will update the kV/kV Single Source calibration file that includes the colinearity parameters, with the correct values. \n\nIf you need assistance, contact the IBA Site Staff or the Operations manager at +32 10 475 997 or email: Sophie.dessart@iba-group.com.",
      "product_quantity": "1",
      "distribution_pattern": "US Distribution in PA only.",
      "openfda": {
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          "K132847",
          "K080886",
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        ],
        "registration_number": [
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        "fei_number": [
          "1038814",
          "3001874253",
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          "3007087027",
          "1721113",
          "3015232217",
          "3008328959"
        ],
        "device_name": "System, Radiation Therapy, Charged-Particle, Medical",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5050",
        "device_class": "2"
      }
    }
  ]
}