{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Louvain La Neuve",
      "state": "",
      "country": "Belgium",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69781",
      "recalling_firm": "Ion Beam Applications S.A.",
      "address_1": "Chemin du Cyclotron, 3",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution in PA only.",
      "recall_number": "Z-0836-2015",
      "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.",
      "product_quantity": "1",
      "reason_for_recall": "Two issues were identified:    1.   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.  2.   A gantry collision  incident required  the IBA service team to verify the gantry alignment and protons  I x-ray  beams  colinearity, du",
      "recall_initiation_date": "20141107",
      "center_classification_date": "20141219",
      "termination_date": "20150629",
      "report_date": "20141231",
      "code_info": "PAT.109 (US), Treatment room 4",
      "more_code_info": ""
    }
  ]
}