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Sign in to claim this brandMevion Medical Systems, Inc.
United States·US-MF-000008692
Last updated September 17, 2026
About
Auburn Installs Superconducting Proton Accelerator for Nation’s Only University-Led Space Electronics Testing Facility of Its KindREAD NOWMevion Announces First Clinical Treatment on the MEVION S250-FIT™ Proton Therapy SystemREAD NOWMevion Medical Systems and Tam Anh General Hospital Partner to Bring Advanced Proton Therapy to VietnamREAD NOWIstituto Nazionale Tumori IRCCS Fondazione G. Pascale Selects MEVION S250-FIT™ for…
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 300 Foster St, Littleton, United States
- Website
- www.mevion.com
- facebook.com/MevionMedical
- [email protected]
- Phone
- +1 9785401500
- PRRC Contact
- Jason Brown
- EUDAMED SRN
- US-MF-000008692
- FDA FEI Number
- 3007087027
- DUNS Number
- —
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mevion Medical Systems | S250 | FDA UDI | Class II | Active |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | K253406 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | K250986 | FDA 510(k) | Class II | Active |
| MEVION S250i Proton Beam Radiation Therapy Device | K172848 | FDA 510(k) | Class II | Active |
| S-250 Proton Beam Radiation Therapy System | K120676 | FDA 510(k) | Class II | Active |
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FDA Recalls (14)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 1, 2022 | Z-0827-2022 | — | open, 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. |
| Oct 19, 2020 | Z-0485-2021 | — | terminated | Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur |
| Jun 23, 2020 | Z-2686-2020 | — | terminated | 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. |
| May 15, 2020 | Z-2406-2020 | — | terminated | 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 |
| Oct 1, 2018 | Z-0705-2019 | — | terminated | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped |
| Jun 29, 2018 | Z-2746-2018 | — | terminated | QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury. |
| Dec 16, 2016 | Z-1122-2017 | — | terminated | An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened |
| Oct 31, 2016 | Z-0409-2017 | — | terminated | Completing Setup Without Program Move Complete Can Cause An Isocenter Error |
| Oct 21, 2016 | Z-0410-2017 | — | terminated | Recovery of Incorrect Isocenter -operational change |
| Oct 20, 2016 | Z-0411-2017 | — | terminated | Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter |
| Mar 15, 2016 | Z-1529-2016 | — | terminated | Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death. |
| Nov 18, 2015 | Z-0767-2016 | — | terminated | The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment. |
| Nov 10, 2014 | Z-0588-2015 | — | terminated | Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%. |
| Mar 5, 2014 | Z-1271-2014 | — | terminated | Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields |