Proteus 235 Proteus PLUS (REF NA)Recalls & reported problems
Ion Beam Applications SA · IBA Proton Therapy System – Proteus 235 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05404013810901), received between May 22, 2018 and May 22, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Component Falling” (1 report).
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.
Most reported problems
Device problems
- Component Falling1
- Device Dislodged or Dislocated1
- Failure to Align1
- Failure to Auto Stop1
- Malposition of Device1
Patient problems
- Abrasion1
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2018Component Falling; Failure to Align; Malposition of Device; Device Dislodged or Dislocated; Failure to Auto Stop; Component Falling; Malposition of Device; Failure to Auto Stop
DESCRIPTION OF THE EVENT: IBA HAS BEEN INFORMED THAT ON (B)(6) 2018 DURING THE PATIENT ALIGNMENT PHASE BEFORE TREATMENT, THE RANGE SHIFTER WAS NOT CORRECTLY ALIGNED ON THE RAILS. WHILE THE GANTRY WAS BEING ROTATED TO THE POSITION PRESCRIBED FOR TREATMENT, THE RANGE SHIFTER (23 POUNDS) BECAME DISLODGED AND FELL ON THE HEAD OF THE PATIENT. IMPACT OF THE EVENT ON THE PATIENT: THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT OF THE HOSPITAL FOR IMAGING AND ASSESSMENT FOR THE HEAD TRAUMA. THE PATIENT DEVELOPED A SMALL ABRASION WITH A SIGNIFICANT UNDERLYING HEMATOMA. THE PATIENT WAS ADMITTED FOR OBSERVATION FOR 24 HOURS. THERE WAS NO EVIDENCE OF SKULL OR CERVICAL-SPINE FRACTURE; HOWEVER, THE HEAD CUP UNDER THE PATIENT'S HEAD/NECK WAS BROKEN AS A RESULT OF THE BLUNT IMPACT. THE HEMATOMA RESOLVED OVER THE NEXT 3 DAYS. IBA IS NOT AWARE OF ANY FOLLOW-UP CARE REQUIRED.
Patient problems: Abrasion; Hematoma
MAUDE report 7532659 ↗
Other System, Radiation Therapy, Charged-Particle, Medical devices
- IBA Proton Therapy System – Proteus 235 Proteus PLUS/Proteus ONEIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical8 recalls1 report
- MEVION S250iMevion Medical Systems, Inc. · System, Radiation Therapy, Charged-Particle, Medical5 recalls5 reports
- Mevion Medical Systems S250Mevion Medical Systems, Inc. · System, Radiation Therapy, Charged-Particle, Medical4 recalls1 report
- PROBEAT PROBEAT-FRHitachi, Ltd. · System, Radiation Therapy, Charged-Particle, Medical2 recalls2 reports
- PROBEAT PROBEAT-CRHitachi, Ltd. · System, Radiation Therapy, Charged-Particle, Medical2 recalls0 reports
- Proteus 235 Proteus PLUSIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical1 recall1 report
- Proteus 235 Proteus ONEIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical2 reports
- I2C (IBA Image-Guided Therapy Console) adaPTinsightIon Beam Applications SA · System, Radiation Therapy, Charged-Particle, Medical1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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