MEVION S250iRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00864366000124), received between Oct 22, 2020 and Jan 15, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (2 reports).

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

1 other recall cover devices cleared under the same FDA submission (K172848); 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 16, 2026.

Recalls naming this device

1. Feb 1, 2022Open, Classified

   Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

   Z-0827-2022 · Root cause: Component design/selection · Recall details · FDA record ↗

2. Oct 19, 2020Terminated

   Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

   Z-0485-2021 · Root cause: Device Design · Recall details · FDA record ↗

3. Jun 23, 2020Terminated

   The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

   Z-2686-2020 · Root cause: Device Design · Recall details · FDA record ↗

4. May 15, 2020Terminated

   Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

   Z-2406-2020 · Root cause: Software design · Recall details · FDA record ↗

5. Oct 1, 2018Terminated

   Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

   Z-0705-2019 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025Intermittent Program or Algorithm Execution; Intermittent Program or Algorithm Execution

  NOVEMBER 29, 2024: RADIATION THERAPISTS AT THE (B)(6) IN THE NETHERLANDS REPORTED AN ISSUE DURING PATIENT SETUP FOR TWO CASES. AFTER APPLYING THE CBCT DELTAS AND COMPLETING THE SETUP, THEY PERFORMED THE DELTA+SAVE FUNCTION AND TRANSITIONED THE SYSTEM TO THE TREATMENT POSITION. HOWEVER, UPON REACHING THE TREATMENT POSITION, THERE WAS A DEVIATION IN THE DISPLAYED DELTA VALUES FROM THE PLANNED DELTA VALUES, WHICH SHOULD NOT OCCUR. IN SUCH INSTANCES, THE PROTOCOL REQUIRES UNLOADING THE PATIENT AND REPEATING CBCT IMAGING. IN THIS CASE, THE ISSUE WAS IDENTIFIED BEFORE TREATMENT BEGAN, DUE TO THE IMPLEMENTED MITIGATIONS, ENSURING NO HARM OR MISTREATMENT OCCURRED. MEVION REVIEWED THE INCIDENT WHEN IT WAS REPORTED AND DETERMINED IT WAS NOT REPORTABLE BECAUSE THE SAFEGUARDS IN PLACE EFFECTIVELY PREVENTED ANY MISTREATMENT. DECEMBER 13, 2024: MEVION HELD AN INTERNAL MEETING TO REVIEW THE SAFETY ANALYSIS OF THE EVENT AND MEVION DECIDED TO PERFORM A LOG REVIEW FOR ALL S250I DEVICES WITH KRC4 COUCHES INSTALLED TO DETERMINE HOW OFTEN THIS RACE CONDITION PRESENTS AND IF PATIENTS WERE TREATED WITH THE INCORRECT DELTAS APPLIED. DECEMBER 17, 2024 (AWARENESS DATE OF FEBRUARY 6, 2024, INCIDENT): LOG ANA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159350 ↗
• MalfunctionMay 22, 2024Application Network Problem; Intermittent Communication Failure; Application Network Problem; Intermittent Communication Failure

  DURING TREATMENT OF PATIENT (B)(6) ON (B)(6) 2024, THERAPISTS NOTED THAT CONTOURS LOOKED ELONGATED ON PATIENT IMAGES, BUT PROCEEDED WITH ALIGNMENT AND TREATMENT. CONTOURS LOOKED AS EXPECTED (NOT ELONGATED) IN OFFLINE REVIEW. PATIENT (B)(6) WAS THE ONLY PATIENT WITH THIS ISSUE, NO OTHER PATIENTS ON (B)(6) HAD THIS ISSUE. WHEN SETTING UP THIS PATIENT ON (B)(6), THERAPISTS NOTED THAT CONTOURS WERE ELONGATED AGAIN. AFTER TREATING, THE PATIENT IMAGES WERE LOOKED AT IN OFFLINE REVIEW AND THE CONTOURS ONCE AGAIN APPEARED AS EXPECTED. THERAPISTS EXPRESSED CONCERNS OF A MISALIGNMENT DUE TO THE ELONGATED CONTOURS. PHYSICIAN REVIEW OF THE RECORDS SHOWED THAT TWO SEPARATE FRACTIONS WERE MISALIGNED, FRACTIONS ON BOTH THE 24TH AND 25TH. THE FIRST FRACTION WAS MISALIGNED BY 0.72CM AND 0.83CM, AND THE SECOND FRACTION WAS MISALIGNED BY 1.3CM AND 1.5CM. NO HARM OR PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370411 ↗
• InjuryFeb 1, 2024Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  ON FRIDAY JANUARY 12, THE FIRST BEAM OF A 5-BEAM FRACTION WAS DELIVERED TO AN INCORRECT POSITION WITH ERRORS OF 3.4 CM IN VERTICAL, 9.3 CM IN LONGITUDINAL AND 6.9 CM IN LATERAL, RESULTING IN AN OVERDOSE TO SURROUNDING TISSUE AND AN UNDERDOSE TO THE TARGET. THIS ERROR WAS CALCULATED TO AMOUNT TO A +/- 2.5% DOSE ERROR (~1.5 GY) OVER THE COURSE OF A SINGLE TREATMENT. THERE WAS NO ADVERSE REACTION TO THE PATIENT REPORTED BY THE FACILITY. THE ROOT CAUSE OF THE INCORRECT DELIVERY WAS DETERMINED TO BE USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625672 ↗
• MalfunctionNov 4, 2020Computer Software Problem; Computer Software Problem

  IN THE EVENT THAT A USER ACTION CAUSES ISOCENTER TO BE LOST DURING THE SETUP WORKFLOW, THE SYSTEM WILL PRESENT ERROR MESSAGES ON THE IN-ROOM MONITOR AND THE TC SCREEN INDICATING THAT DELTAS WERE NOT APPLIED DURING SETUP OR A PROGRAM MOVE COMPLETE (PMC) WAS NOT ACHIEVED. WHEN THE SETUP FIELD IS CLOSED ANOTHER ERROR MESSAGE APPEARS ON THE TC THAT INFORMS THE USER OF A PROBLEM, WHICH THEY MUST CORRECT. THE USER IS PREVENTED FROM PROCEEDING TO A TREATMENT FIELD UNTIL THE SETUP IS CORRECTED AND THE SETUP FIELD IS CLOSED WITH A PMC. THE AUTO-FIELD SEQUENCING OPTION AS CURRENTLY IMPLEMENTED, AUTOMATICALLY LOADS THE FIRST TREATMENT FIELD AFTER THE ABOVE ERROR MESSAGE IS ACKNOWLEDGED. THE WORKFLOW IS PERMITTED TO PROCEED TO TREATMENT. ADDITIONAL WARNINGS WILL APPEAR BEFORE EACH BEAM CAN BE TURNED ON, BUT THOSE WARNINGS MAY BE IMPROPERLY IGNORED. IF THE INCOMPLETE MOVE AND LOST ISOCENTER PUTS THE PATIENT A SIGNIFICANT DISTANCE AWAY FROM THE PRESCRIBED POSITION, A MISADMINISTRATION DUE TO A GEOGRAPHIC MISS IS POSSIBLE.

  Patient problems: Erythema

  MAUDE report 10787991 ↗
• MalfunctionOct 22, 2020Computer Software Problem; Computer Software Problem

  CUSTOMER REPORTED UPON INITIATION OF A TREATMENT BEAM, THE TREATMENT CONSOLE (TC) SCREEN UNEXPECTEDLY TERMINATED THE BEAM AND BLANKED OUT THE CURRENT FIELD DELIVERY INFORMATION. THE MONITOR UNIT (MU) COUNTER ON THE TOP RIGHT OF THE TC SCREEN CONTINUED TO INCREMENT UP, AND THE BEAM CONTROL BOX CONTINUED TO EMIT BEEPING SOUNDS CONSISTENT WITH BEAM DELIVERY. NO DICOM RECORD FOR THAT BEAM WAS CREATED OR SENT TO THE ONCOLOGY INFORMATION SYSTEM (OIS), AND THE RECORDS ACCESSIBLE TO THE USERS SHOWED NO DELIVERY OF DOSE TO THAT FIELD. THIS LEFT THE THERAPIST AND PHYSICIST UNCERTAIN AS TO HOW MUCH BEAM WAS DELIVERED. HAD THE USERS DECIDED TO DELIVER THE SAME BEAM AGAIN THE PATIENT COULD BE OVER TREATED. THE HARDWIRED MONITOR UNIT COUNTER (HMUC) LOCATED IN THE SYSTEM CABINET ACCURATELY CAPTURED THE DOSE DELIVERED BUT WAS NOT RECORDED BEFORE A SUBSEQUENT USER ACTION CLEARED THAT COUNTER.

  Patient problems: Erythema

  MAUDE report 10719879 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172848. One submission often covers many models, so check the product and lot details in each record.

• Z-2746-2018 · Jun 29, 2018 · Terminated
  MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other