{
  "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": "188066",
      "product_res_number": "Z-2155-2021",
      "event_date_initiated": "2021-05-26",
      "event_date_created": "2021-07-28",
      "recall_status": "Open, Classified",
      "res_event_number": "88196",
      "product_code": "LHN",
      "k_numbers": [
        "K101508"
      ],
      "product_description": "Proteus 235-Proton Therapy System",
      "code_info": "Serial Numbers:\nPAT.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).",
      "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": "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",
      "root_cause_description": "Labeling design",
      "action": "IBA  issued  Urgent Medical Device Correction notification starting on May 27, 2021.\nLetter states reason for recall, health risk and action to take:\nIBA would like to remind Proteus235 users of the following warning\npresent in the Clinical User Guide:\nAs a Radiation Therapy Technologist (RTT), check before allowing\nthe irradiation that the position of the selector switch of the external\nbeam triggering interface is consistent with the prescription data in the\npatient file. There is a risk of mistreatment as the system does not\nautomatically detect the gating prescription thereby always generating\na continuous irradiation.\n\nLabelling change and training \nIBA will:\n- update the user manuals to recommend the customers to define a procedure for patients with gating prescribed in order to ensure that the system will be set correctly,\n- provide user training sessions about the preparation of a treatment with UBTI synchronization.\nThe actions will be performed for your site by December 31, 2021.\n\nYour IBA representative is able to provide you with additional information and/or guidelines if necessary.",
      "product_quantity": "5 US; 8 OUS",
      "distribution_pattern": "FL,  PA, TN, TX, VA\n\nForeign: \nGermany, Italy, Russia, Sweden , India, Netherlands",
      "openfda": {
        "k_number": [
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          "K201798",
          "K152207",
          "K891261",
          "K124002",
          "K220883",
          "K080886",
          "K093250",
          "K243900",
          "K160432",
          "K221996",
          "K152224",
          "K134052",
          "K191801",
          "K992414",
          "K092796",
          "K073059",
          "K032511",
          "K200282",
          "K170719",
          "K133191",
          "K031385",
          "K082416",
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          "K091629",
          "K160612",
          "K161163",
          "K852907",
          "K101508",
          "K201042",
          "K163500",
          "K221791",
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          "K973960",
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          "K191821",
          "K983629",
          "K032886",
          "K060834",
          "K002194",
          "K260174",
          "K162246"
        ],
        "registration_number": [
          "3009754495",
          "9613183",
          "2953704",
          "3010658895",
          "9681124",
          "3008317830",
          "2032229",
          "9614952",
          "3007087027",
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          "1721113",
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          "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"
      }
    }
  ]
}