Ion Beam Applications S.A.
LOUVAIN-LA-NEUVE, BE Brabant Wallon, BE
ION BEAM APPLICATIONS S.A. appears in FDA device records in LOUVAIN-LA-NEUVE, BE Brabant Wallon, BE. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 36 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Ion Beam Applications S.A. between 2001 and 2017. The busiest year on record is 2006, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2006 | 3 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | LHN | Substantially Equivalent | |
| K132919 | GANTRY BEAM LINE | LHN | Substantially Equivalent | |
| K132847 | I2C | LHN | Substantially Equivalent | |
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 | LHN | Substantially Equivalent | |
| K100766 | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 | LHN | Substantially Equivalent | |
| K092796 | IBA PROTON THERAPY SYSTEM, PROTEUS 235 | LHN | Substantially Equivalent | |
| K091629 | PROTEUS 235 PROTON THERAPY SYSTEM | LHN | Substantially Equivalent | |
| K083058 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | LHN | Substantially Equivalent | |
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 | LHN | Substantially Equivalent | |
| K061913 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | LHN | Substantially Equivalent | |
| K060695 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | LHN | Substantially Equivalent | |
| K053641 | IBA PROTON THERAPY SYSTEM-PROTEUS 235 | LHN | Substantially Equivalent | |
| K983024 | PROTON THERAPY SYSTEM | LHN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3000256071 | 3000256071 | ION BEAM APPLICATIONS S.A. | 3 CHEMIN DU CYCLOTRON, LOUVAIN-LA-NEUVE, BE Brabant Wallon 1348 BE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 36| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1497-2026 | 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. | Class II | Open, Classified | |
| Z-2693-2024 | 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 | Class II | Open, Classified | |
| Z-3089-2024 | 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 | Class II | Open, Classified | |
| Z-1945-2024 | 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 | Class II | Open, Classified | |
| Z-1603-2024 | 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. | Class II | Open, Classified | |
| Z-0295-2024 | 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. | Class II | Open, Classified | |
| Z-1205-2022 | 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 | Class II | Open, Classified | |
| Z-0747-2022 | 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 | Class II | Open, Classified | |
| Z-0466-2022 | 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 the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments. | Class II | Terminated | |
| Z-2434-2021 | 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 | Class II | Open, Classified | |
| Z-2155-2021 | 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 | Class II | Open, Classified | |
| Z-2715-2020 | 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 other conditions susceptible to treatment by radiation. | IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded. | Class II | Terminated | |
| Z-2773-2020 | 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 other conditions susceptible to treatment by radiation. | 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 Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam. | Class II | Terminated | |
| Z-0698-2019 | 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 localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. | There is a risk of detachment of the Compact Gantry Rolling Floor. | Class II | Terminated | |
| Z-2470-2018 | 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 conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. | 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. | Class II | Terminated | |
| Z-2424-2018 | 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 radiation. | 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. | Class II | Terminated | |
| Z-1477-2018 | 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 treatment field without analyzing the cause for the error message. This may lead to under-irradiation. 2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose. | Class II | Terminated | |
| Z-0934-2018 | 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 patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. | 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. | Class II | Terminated | |
| Z-0938-2018 | 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. | Class II | Terminated | |
| Z-0943-2018 | 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 treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. | The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. | Class II | Terminated | |
| Z-0931-2018 | 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 treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck. | Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not. | Class II | Terminated | |
| Z-0930-2018 | Proteus 235, graphite block 8 | IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader | Class II | Terminated | |
| Z-2097-2017 | 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 radiation. | 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. | Class II | Terminated | |
| Z-1830-2017 | 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. | Class II | Terminated | |
| Z-1695-2017 | Proteus 235 | The Proton Therapy System can allow gantry rotation even if the snout is not properly locked. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Ion Beam Applications S.A. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain