Data / Medical devices / Belgium / Ion Beam Applications S.A.
Ion Beam Applications S.A.: FDA-registered device maker in LOUVAIN-LA-NEUVE, BE Brabant Wallon, Belgium, 2 510(k) clearances
Ion Beam Applications S.A. is registered with the FDA (registration 3000256071) in LOUVAIN-LA-NEUVE, BE Brabant Wallon, Belgium. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 17, 2017. 35 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000256071
- Address
- 3 Chemin Du Cyclotron, LOUVAIN-LA-NEUVE, BE Brabant Wallon, Belgium, 1348
- Owner or operator
- ION BEAM APPLICATIONS S.A. (9034929)
- Roles
- Manufacturer
- First device listed
- November 3, 2014
- Registered through
- 2026
- Brand names listed
- K132847, Proteus One, Proteus Plus, Proton Therapy System - Proteus 235
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 17, 2017 | K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | LHN | Substantially Equivalent | Ion Beam Applications S.A. | accessdata.fda.gov |
| November 20, 2013 | K132847 | I2C | LHN | Substantially Equivalent | Ion Beam Applications S.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 3, 2026 | 98364 | Class II | Ongoing | IBA Proton Therapy System - PROTEUS 235 | 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. | accessdata.fda.gov |
| July 10, 2024 | 95024 | Class II | Ongoing | IBA Proton Therapy System - 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 | Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues | accessdata.fda.gov |
| July 8, 2024 | 95080 | Class II | Ongoing | IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions | Safety Parameters Verification Mechanisms can be deactivated in clinical runtime | accessdata.fda.gov |
| May 10, 2024 | 94576 | Class II | Ongoing | IBA Proton Therapy System - 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. | Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances | accessdata.fda.gov |
| March 4, 2024 | 94297 | Class II | Ongoing | IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions. | There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. | accessdata.fda.gov |
| September 18, 2023 | 93293 | Class II | Ongoing | IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System. | The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices. | accessdata.fda.gov |
| April 20, 2022 | 90213 | Class II | Ongoing | Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation | First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed | accessdata.fda.gov |
| February 15, 2022 | 89731 | Class II | Ongoing | 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 | 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 | accessdata.fda.gov |
| November 29, 2021 | 89267 | Class II | Terminated | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where | accessdata.fda.gov |
| June 14, 2021 | 88449 | Class II | Ongoing | 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 | Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment | accessdata.fda.gov |
| May 26, 2021 | 88196 | Class II | Ongoing | Proteus 235-Proton Therapy System | 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 | accessdata.fda.gov |
| July 17, 2020 | 86076 | Class II | Terminated | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and ot | IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded. | accessdata.fda.gov |
| April 21, 2020 | 86073 | Class II | Terminated | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and ot | Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic | accessdata.fda.gov |
| December 12, 2018 | 81807 | Class II | Terminated | Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localize | There is a risk of detachment of the Compact Gantry Rolling Floor. | accessdata.fda.gov |
| June 27, 2018 | 80384 | Class II | Terminated | Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other cond | Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient. | accessdata.fda.gov |
| May 16, 2018 | 80298 | Class II | Terminated | Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by | Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position. | accessdata.fda.gov |
| January 26, 2018 | 79605 | Class II | Terminated | Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. | When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible: 1. The user resumes the tr | accessdata.fda.gov |
| December 5, 2017 | 79231 | Class II | Terminated | Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of pat | An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate. | accessdata.fda.gov |
| November 17, 2017 | 79230 | Class II | Terminated | Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. | There is a risk of misalignment of the patient when using treatment plans with multiple isocenters. | accessdata.fda.gov |
| November 1, 2017 | 79229 | Class II | Terminated | Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the tre | The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. | accessdata.fda.gov |
| October 19, 2017 | 79228 | Class II | Terminated | Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatme | Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. | accessdata.fda.gov |
| October 17, 2017 | 79227 | Class II | Terminated | Proteus 235, graphite block 8 | IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader | accessdata.fda.gov |
| April 10, 2017 | 76977 | Class II | Terminated | Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by rad | A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose. | accessdata.fda.gov |
| March 21, 2017 | 76804 | Class II | Terminated | Proteus 235, Proton Therapy System | In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data. | accessdata.fda.gov |
| March 9, 2017 | 76696 | Class II | Terminated | Proteus 235 | The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. | accessdata.fda.gov |
| February 9, 2017 | 77175 | Class II | Terminated | Proteus 235 | It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers. | accessdata.fda.gov |
| December 13, 2016 | 77621 | Class II | Terminated | Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other co | Software issue | accessdata.fda.gov |
| October 28, 2016 | 80219 | Class II | Terminated | 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equi | IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem. | accessdata.fda.gov |
| September 16, 2016 | 80221 | Class II | Terminated | 12C | IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk. | accessdata.fda.gov |
| August 7, 2016 | 80222 | Class II | Terminated | Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a | IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement. | accessdata.fda.gov |
| May 18, 2016 | 77620 | Class II | Terminated | Proteus 235 and Proteus ONE proton therapy systems | Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures. | accessdata.fda.gov |
| April 11, 2016 | 80217 | Class II | Terminated | The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) | IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue. | accessdata.fda.gov |
| November 7, 2014 | 69781 | Class II | Terminated | adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to pr | Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams c | accessdata.fda.gov |
| March 27, 2014 | 68846 | Class II | Terminated | Proteus 235 Proton Therapy System for cancer treatment. | While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a s | accessdata.fda.gov |
| December 4, 2013 | 67678 | Class II | Terminated | Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy | Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0). | accessdata.fda.gov |
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Updated March 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.