Proteus 235Recalls & reported problems across all models

We found 3 models of Proteus 235 by Ion Beam Applications SA in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between May 22, 2018 and Jun 17, 2022 — classified as 3 injuries, 1 malfunction.

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

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Proteus 235 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

Most reported Proteus 235 problems

Proteus 235 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Proteus 235 Proteus PLUS

  System, Radiation Therapy, Charged-Particle, Medical
  1 recall1 report
• Proteus 235 Proteus ONE

  System, Radiation Therapy, Charged-Particle, Medical
  2 reports
• Proteus 235 Proteus PLUS

  System, Radiation Therapy, Charged-Particle, Medical
  1 report

Recent Proteus 235 adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: ON MAY 19, 2022, IBA WAS MADE AWARE THAT A PATIENT DEVELOPED A DELAYED UNANTICIPATED SKIN REACTION FOLLOWING A PROTON THERAPY TREATMENT COMPLETED MID-MARCH 2022. THIS REACTION WAS DISCOVERED DURING A CLINICAL FOLLOW-UP ON MAY 18, 2022. EXCESSIVE SKIN REACTION CAN BE EXPLAINED BY DIFFERENT CAUSES. IBA'S INVESTIGATION IS ONGOING. THE PRELIMINARY RESULTS SHOW THAT THE SYSTEM BEHAVED AS EXPECTED, WITHOUT ANY MALFUNCTION. FURTHERMORE, THE IMPACTED PATIENT RECEIVED A VACCINE AGAINST COVID-19 AND RADIATION RECALL DERMATITIS CASES HAVE BEEN REPORTED AS MORE FREQUENT WITH THE ADMINISTRATION OF COVID-19 VACCINE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. IBA REFERENCE: (B)(4).

  Patient problems: Radiodermatitis

  MAUDE report 14731606 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  ON APRIL 28, 2022, IBA WAS MADE AWARE THAT A PATIENT DEVELOPED A SEVERE SKIN REACTION FOLLOWING A PROTON THERAPY TREATMENT THAT WAS STARTED ON (B)(6) 2022. EXCESSIVE SKIN REACTIONS CAN BE EXPLAINED BY DIFFERENT CAUSES. IBA'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Radiodermatitis

  MAUDE report 14497661 ↗
• 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 ↗
• 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 ↗