{
  "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": "89731",
      "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": "IL, KS, LA,  FL, MI, OK, PA, NJ,  TN, TX, VA, WA   Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South  Korea, Taiwan, Netherlands,",
      "recall_number": "Z-0747-2022",
      "product_description": "ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation  Proteus 235",
      "product_quantity": "15 units US; 22 units OUS",
      "reason_for_recall": "When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range",
      "recall_initiation_date": "20220215",
      "center_classification_date": "20220310",
      "report_date": "20220316",
      "code_info": "PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT109  (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US),  PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU),  SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU),  SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132  (EU), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (EU),  SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.109  (UK), SBF.110 (UK), SBF.112 (EU), SBF.113 (US), SBF.115 (UK),  SBF.117 (EU), SBF.128 (US).    UDI: (01)05404013801138"
    }
  ]
}