Print-ready dossier — use your browser's print dialog to save as PDF.

IBA Proton Therapy System – Proteus 235

Model Proteus PLUS/Proteus ONE · Ion Beam Applications SA · DI 05404013801138

LHN — System, Radiation Therapy, Charged-Particle, Medical · Class II · 21 CFR 892.5050

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (11)

Initiated	Recall #	Class	Status	Reason	Link basis
2026-02-03	Z-1497-2026	Class II	Open, Classified	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.	code info di
2024-07-10	Z-2693-2024	Class II	Open, Classified	Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues	code info di
2024-07-08	Z-3089-2024	Class II	Open, Classified	Safety Parameters Verification Mechanisms can be deactivated in clinical runtime	code info di
2024-05-10	Z-1945-2024	Class II	Open, Classified	Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances	code info di
2024-03-04	Z-1603-2024	Class II	Open, Classified	There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.	code info di
2023-09-18	Z-0295-2024	Class II	Open, Classified	The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.	code info di
2022-04-20	Z-1205-2022	Class II	Open, Classified	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	code info di
2022-02-15	Z-0747-2022	Class II	Open, Classified	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	code info di
2021-11-29	Z-0466-2022	Class II	Terminated	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.	k number procode
2020-07-17	Z-2715-2020	Class II	Terminated	IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.	k number procode
2020-04-21	Z-2773-2020	Class II	Terminated	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.	k number procode

Adverse-event reports — MAUDE (1)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 1

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2020-06	0	1
2020-10	0	2
2020-11	0	2
2020-12	0	8
2021-01	0	9
2021-02	0	6
2021-03	0	1
2022-02	0	1
2022-05	0	1
2022-06	0	1
2022-11	0	1
2022-12	0	1
2023-04	1	1
2024-02	0	1
2024-05	0	1
2025-01	0	2
2025-12	0	1
2026-01	0	1
2026-03	0	12
2026-06	0	2

This device (reports/month)Average device in LHN (reports/device/month)

Regulatory clearances

K163500 SESE 2017-08-17 (k number procode)

Predicate lineage

K163500 — cites (transitively): K152224 (d1), K120676 (d2), K132919 (d2), K053280 (d3), K053641 (d3), K061913 (d3), K101294 (d3), K872369 (d3), K983332 (d3)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Ion Beam Applications SA

Nothing in the loaded window.