{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Louvain-la-neuve",
      "state": "N/A",
      "country": "Belgium",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88196",
      "recalling_firm": "Ion Beam Applications S.A.",
      "address_1": "Chemin Du Cyclotron 3",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "FL,  PA, TN, TX, VA    Foreign:   Germany, Italy, Russia, Sweden , India, Netherlands",
      "recall_number": "Z-2155-2021",
      "product_description": "Proteus 235-Proton Therapy System",
      "product_quantity": "5 US; 8 OUS",
      "reason_for_recall": "if the user forgets to select the trigger  input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position",
      "recall_initiation_date": "20210526",
      "center_classification_date": "20210728",
      "report_date": "20210804",
      "code_info": "Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US)."
    }
  ]
}