IBA Proton Therapy System – Proteus 235 · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

1 linked reportMalfunction 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)

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	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.Distribution: Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.	4 units (1 US, 3 OUS)	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 issuesDistribution: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden	19 units	code info di
2024-07-08	Z-3089-2024	Class II	Open, Classified	Safety Parameters Verification Mechanisms can be deactivated in clinical runtimeDistribution: Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.	35 units	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 tolerancesDistribution: Worldwide - US Nationwide distribution in the state of Virginia and the country of India.	2 units	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.Distribution: US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.	8 units	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.Distribution: Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.	5 (US), 9 (OUS)	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 prescribedDistribution: Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.	4 units	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 rangeDistribution: IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,	15 units US; 22 units OUS	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.Distribution: IN USA: VA, OK, NJ, TN OUS: Czech Republic.	5 devices	clearance family
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.Distribution: US: VA OUS: Belgium	2 Units	clearance family

Showing 1–10 of 11

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2023-04-07	3000256071-2023-00001	Malfunction	Available	exact di

Regulatory clearances

510(k)K163500Substantially equivalent (SESE) · 2017-08-17clearance family

Predicate lineage

K163500
- K152224
  - K120676
  - K132919

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

None in the loaded window.

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