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Proteus 235 Proteus PLUS (REF NA)Recalls & reported problems

Ion Beam Applications SA · IBA Proton Therapy System – Proteus 235 · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05404013814015), received between Jun 18, 2020 and Jun 18, 2020 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 10, 2024Open, 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 · FDA record ↗

Most reported problems

Device problems

  • Data Problem1
  • Failure to Transmit Record1
  • Imprecision1

Patient problems

  • Radiation Overdose1
  • Radiation Underdose1

Recent adverse event reports

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

  • MalfunctionJun 18, 2020Imprecision; Failure to Transmit Record; Data Problem; Imprecision; Failure to Transmit Record; Data Problem

    EVENT DESCRIPTION : ON (B)(6) 2020, DURING THE PREPARATION FOR A TREATMENT, AN ABORT OCCURRED WHEN AN ABNORMAL BEAM WAS DETECTED. IT WAS NOT POSSIBLE TO RESUME MANUALLY THE PARTIAL TREATMENT FROM DCEU (DOSIMETRY COUNTER ELECTRONIC UNIT) VALUE, BUT THE TPS (TREATMENT PLANNING SYSTEM) WAS USED TO MAKE A SINGLE PRESCRIBED BEAM OF THE NORMAL BEAM SKIPPING THE ALREADY DELIVERED SPOTS. PRELIMINARY ANALYSIS : THE ISSUE IS UNDER ANALYSIS AND IS REPORTED PREVENTIVELY. SUPPLEMENTAL REPORT WILL INCLUDE ANALYSIS OF THE ISSUE.

    Patient problems: Radiation Overdose; Radiation Underdose

    MAUDE report 10168195 ↗

Other System, Radiation Therapy, Charged-Particle, Medical devices

All System, Radiation Therapy, Charged-Particle, Medical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.