{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218471",
      "product_res_number": "Z-1497-2026",
      "event_date_initiated": "2026-02-03",
      "event_date_posted": "2026-03-06",
      "recall_status": "Open, Classified",
      "res_event_number": "98364",
      "product_code": "LHN",
      "k_numbers": [
        "K163500"
      ],
      "product_description": "IBA Proton Therapy System - PROTEUS 235",
      "code_info": "PROTEUS 235;\nUDI-DI: 05404013801138;\nSerial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)",
      "firm_fei_number": "3000256071",
      "recalling_firm": "Ion Beam Applications S.A.",
      "address_1": "Chemin Du Cyclotron 3 3 chemin du cyclotron",
      "city": "Ottignies-Louvain-La-Neuve",
      "country": "Belgium",
      "additional_info_contact": "Inez Wathion\n104758811",
      "reason_for_recall": "It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the  Healthy Signal  from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.",
      "root_cause_description": "Software design",
      "action": "On February 3, 2026 Urgent Medical Device Correction letters were sent to customers.\nLetter provides awareness of the Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. On-site modification of the devices will be performed by IBA with a TSS Configuration update. The update will be deployed at the impacted sites by June 2026.",
      "product_quantity": "4 units (1 US, 3 OUS)",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.",
      "openfda": {
        "k_number": [
          "K172848",
          "K112969",
          "K132847",
          "K231863",
          "K092653",
          "K982952",
          "K851301",
          "K982937",
          "K060695",
          "K053280",
          "K160063",
          "K153614",
          "K860606",
          "K191521",
          "K102373",
          "K983342",
          "K120676",
          "K181498",
          "K252815",
          "K061051",
          "K972211",
          "K061913",
          "K101294",
          "K130426",
          "K983660",
          "K112981",
          "K152592",
          "K132919",
          "K171049",
          "K983024",
          "K071399",
          "K052118",
          "K181676",
          "K981358",
          "K100766",
          "K080799",
          "K112768",
          "K972212",
          "K151132",
          "K201798",
          "K152207",
          "K891261",
          "K124002",
          "K220883",
          "K080886",
          "K093250",
          "K243900",
          "K160432",
          "K221996",
          "K152224",
          "K134052",
          "K191801",
          "K992414",
          "K092796",
          "K073059",
          "K032511",
          "K200282",
          "K170719",
          "K133191",
          "K031385",
          "K082416",
          "K250986",
          "K091629",
          "K160612",
          "K161163",
          "K852907",
          "K101508",
          "K201042",
          "K163500",
          "K221791",
          "K133914",
          "K973960",
          "K983332",
          "K053641",
          "K242418",
          "K083058",
          "K253406",
          "K853964",
          "K981115",
          "K232032",
          "K061152",
          "K981112",
          "K953391",
          "K062891",
          "K181789",
          "K191821",
          "K983629",
          "K032886",
          "K060834",
          "K002194",
          "K260174",
          "K162246"
        ],
        "registration_number": [
          "3009754495",
          "9613183",
          "2953704",
          "3010658895",
          "9681124",
          "3008317830",
          "2032229",
          "9614952",
          "3007087027",
          "2916710",
          "1038814",
          "3003993895",
          "1721113",
          "3015178562",
          "3042022819",
          "3000256071",
          "1062572",
          "3006579682",
          "8043933",
          "3010726836",
          "3005374502",
          "3015232217",
          "1000162206",
          "3004977335",
          "2247992",
          "3016872563",
          "8031557"
        ],
        "fei_number": [
          "3003166990",
          "3009754495",
          "3008328959",
          "3010658895",
          "3008317830",
          "3007087027",
          "2916710",
          "3002619595",
          "3001238439",
          "1038814",
          "3003993895",
          "1721113",
          "3015178562",
          "3042022819",
          "3001874253",
          "3006653576",
          "1000208827",
          "3000256071",
          "3006579682",
          "3010726836",
          "1000227792",
          "3007360740",
          "1270485",
          "3015232217",
          "1000162206",
          "3004977335",
          "3016872563"
        ],
        "device_name": "System, Radiation Therapy, Charged-Particle, Medical",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5050",
        "device_class": "2"
      }
    }
  ]
}