IBA Proton Therapy System – Proteus 235 Proteus PLUS/Proteus ONERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05404013801138), received between Apr 7, 2023 and Apr 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Calibration Problem” (1 report).

8 FDA recall records name this device's identifier, 8 still open.

3 other recalls cover devices cleared under the same FDA submission (K163500); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 3, 2026Class IIOpen, 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.

   Z-1497-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Jul 10, 2024Class IIOpen, Classified

   Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

   Z-2693-2024 · Root cause: Process design · Recall details · FDA record ↗

3. Jul 8, 2024Class IIOpen, Classified

   Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

   Z-3089-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. May 10, 2024Class IIOpen, Classified

   Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

   Z-1945-2024 · Root cause: Device Design · Recall details · FDA record ↗

5. Mar 4, 2024Class IIOpen, Classified

   There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

   Z-1603-2024 · Root cause: Device Design · Recall details · FDA record ↗

6. Sep 18, 2023Class IIOpen, Classified

   The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

   Z-0295-2024 · Root cause: Device Design · Recall details · FDA record ↗

7. Apr 20, 2022Class IIOpen, 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

   Z-1205-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Feb 15, 2022Class IIOpen, 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

   Z-0747-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Failure to Align; Calibration Problem; Failure to Align; Calibration Problem

  IBA REFERENCE: (B)(4) DESCRIPTION OF THE EVENT: ON (B)(6) 2023, AS PART OF A PREVENTIVE MAINTENANCE, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE. THE MEASUREMENTS SHOWED A MAXIMUM ERROR IN POSITION OF THE PATIENT POSITIONING SYSTEM (PPS) IN GANTRY TREATMENT ROOM 3 OF 3,4 MM. HOWEVER, THIS PROCEDURE IS CARRIED OUT ON A SINGLE POINT OF THE TREATMENT VOLUME AND DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME. THEREFORE, IBA IS REPORTING THIS EVENT PREVENTIVELY. IMPACT OF THE EVENT: AN ERROR IN POSITION AT THE PPS LEVEL WILL BE IDENTIFIED IF THE USER ACQUIRES X-RAY IMAGES AFTER APPLYING THE CORRECTION VECTOR AS RECOMMENDED IN THE PROTEUS 235 - CLINICAL USER GUIDE. THIS MITIGATION CANNOT BE CONSIDERED AS EFFECTIVE IN ALL CASES AS, DEPENDING ON THE TREATMENT PLAN, MECHANICAL INTERFERENCES BETWEEN THE PPS AND THE FLAT PANELS MAY PREVENT THE ACQUISITION OF X-RAY IMAGES FOR SOME POSITIONS OF THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE IS A RISK OF A NON-DETECTED ERROR IN POSITION UP TO 5 MM FOR POSITIONS WHERE IMAGING THE PATIENT WITH X-RAY IS NOT POSSIBLE BECAUSE OF THESE MECHANICAL INTERFERENCES. THE ERROR WOULD VARY CONTINUOUSLY OVE

  Patient problems: Insufficient Information

  MAUDE report 16699421 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163500. One submission often covers many models, so check the product and lot details in each record.

• Z-0466-2022 · Nov 29, 2021 · Terminated
  Proteus 235; Version: PTS-8 versions before PTS-8.7.2
• Z-2715-2020 · Jul 17, 2020 · 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
• Z-2773-2020 · Apr 21, 2020 · 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