{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "188701", "product_res_number": "Z-2434-2021", "event_date_initiated": "2021-06-14", "event_date_posted": "2021-09-08", "recall_status": "Open, Classified", "res_event_number": "88449", "product_code": "LHN", "k_numbers": [ "K061913" ], "product_description": "Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation", "code_info": "PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US),\nPAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU),\nSAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU),\nSAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132\n(EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US),\nSBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US),\nSBF.115 (UK), SBF.117 (EU).", "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": "Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment", "root_cause_description": "Device Design", "action": "IBA issued an Urgent Medical Device Correction notification users of the device, starting June 14, 2021. Letter states reason for recall, health risk and action to take:\nIBA would like to remind Proteus235 users to verify with X-ray images\nor other means, after the display of the popup message, that the\npatient positions (represented by the couch position, mainly the 3\ntranslations and 3 rotations parameters) recorded in the OIS are\ncorrect Labelling change\nIBA will update the user manuals to:\n- Describe under which conditions the popup message appears\nand the subsequent risks, especially that the equipment\npositions may not be up to date in the OIS,\n- Remind the user to verify with X-ray images or other means,\nafter the display of the popup message, that the patient\npositions (represented by the couch position, mainly the 3\ntranslations and 3 rotations parameters) recorded in the OIS\nare correct,\n- Recommend the user to verify the OIS user manuals for\nmeasures preventing saving outdated patient positions in case\nof disconnection and to apply these measures before saving\nthe positions in the OIS.\nThe action will be completed for your site by May 31, 2022.\n\nBy signing below, the customer representative confirms that this notice has been read,\nunderstood and communicated to the appropriate employees within the organization.\nPlease transfer this notice to other organizations on which this action has an impact.\n\nYour IBA representative is able to provide you with additional information and/or guidelines if necessary.\nPlease return the copy of the notice signed to IBA within 10 working days .", "product_quantity": "27 worldwide, 11 in U.S.", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.", "openfda": { "k_number": [ "K162246", "K052118", "K163500", "K083058", "K852907", "K100766", "K130426", "K860606", "K243900", "K061051", "K061152", "K252815", "K221996", "K092653", "K152224", "K071399", "K231863", "K102373", "K181676", "K112969", "K080799", "K983660", "K250986", "K151132", "K160063", "K191521", "K160432", "K153614", "K242418", "K152207", "K112981", "K073059", "K093250", "K132847", "K992414", "K981358", "K171049", "K981115", "K973960", "K191821", "K120676", "K133191", "K132919", "K191801", "K101508", "K124002", "K082416", "K232032", "K172848", "K091629", "K062891", "K060834", "K983332", "K061913", "K032886", "K983342", "K201798", "K181789", "K053280", "K031385", "K891261", "K260174", "K983629", "K972211", "K983024", "K982937", "K152592", "K200282", "K982952", "K981112", "K053641", "K221791", "K060695", "K032511", "K112768", "K201042", "K101294", "K851301", "K853964", "K133914", "K160612", "K953391", "K002194", "K181498", "K134052", "K080886", "K092796", "K170719", "K220883", "K253406", "K972212", "K161163" ], "registration_number": [ "9614952", "2032229", "8043933", "9613183", "3003993895", "1062572", "2953704", "3008317830", "1721113", "3015232217", "3010726836", "3042022819", "3016872563", "3006579682", "3010658895", "3000256071", "3015178562", "2247992", "2916710", "3004977335", "3009754495", "1038814", "1000162206", "3007087027", "9681124", "8031557", "3005374502" ], "fei_number": [ "1270485", "3008328959", "3003993895", "3008317830", "1721113", "3015232217", "1000227792", "3010726836", "3042022819", "3007360740", "3016872563", "3006579682", "3006653576", "3010658895", "3000256071", "3015178562", "2916710", "3004977335", "3009754495", "1038814", "1000162206", "3007087027", "3001874253", "3003166990", "1000208827", "3002619595", "3001238439" ], "device_name": "System, Radiation Therapy, Charged-Particle, Medical", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }