Mevion Medical Systems S250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00864366000100), received between Jan 13, 2017 and Jan 13, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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

9 other recalls cover devices cleared under the same FDA submission (K120676); 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 1, 2022Class IIOpen, 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, 2020Class IITerminated

   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, 2020Class IITerminated

   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, 2020Class IITerminated

   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 ↗

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.

• InjuryJan 13, 2017Improper or Incorrect Procedure or Method

  DURING PATIENT SETUP, A RADIATION THERAPIST FAILED TO NOTE THE DISTANCE BETWEEN THE TREATMENT MACHINE APPLICATOR (THE DELIVERY HEAD OF THE TREATMENT MACHINE) AND THE TREATMENT TABLE AND PINCHED HER FINGER BETWEEN THE APPLICATOR AND THE TREATMENT TABLE. AS THE APPLICATOR APPROACHES THE TREATMENT AREA, IT ENTERS A SLOW MODE OF MOVEMENT TO PREVENT INJURIES. THE THERAPISTS ARE TRAINED AND WARNED IN THE INSTRUCTIONS FOR USE TO CAREFULLY MONITOR APPLICATOR POSITION WHEN MOVING IT INTO TREATMENT LOCATION.

  Patient problems: Pain

  MAUDE report 6249580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120676. 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
• Z-1122-2017 · Dec 16, 2016 · Terminated
  MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
• Z-0409-2017 · Oct 31, 2016 · Terminated
  MEVION S250 Product Usage: Proton Radiation Therapy
• Z-0410-2017 · Oct 21, 2016 · Terminated
  MEVION S250 Product Usage: Proton Radiation Therapy System
• Z-0411-2017 · Oct 20, 2016 · Terminated
  MEVION S250 Product Usage: Proton Radiation Therapy System
• Z-1529-2016 · Mar 15, 2016 · Terminated
  MEVION S250 for Proton Radiation Therapy
• Z-0767-2016 · Nov 18, 2015 · Terminated
  MEVION S250 Radiation therapy system
• Z-0588-2015 · Nov 10, 2014 · Terminated
  MEVION S250, used for proton radiation therapy.
• Z-1271-2014 · Mar 5, 2014 · Terminated
  MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy