Mevion Medical Systems, Inc.
Littleton, MA, US
MEVION MEDICAL SYSTEMS, INC. appears in FDA device records in Littleton, MA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 14 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Mevion Medical Systems, Inc. between 2012 and 2026. The busiest year on record is 2012, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2017 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | LHN | Substantially Equivalent | |
| K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | LHN | Substantially Equivalent | |
| K172848 | MEVION S250i Proton Beam Radiation Therapy Device | LHN | Substantially Equivalent | |
| K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM | LHN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007087027 | 3007087027 | MEVION MEDICAL SYSTEMS, INC. | 300 Foster St, Littleton, MA 01460 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0827-2022 | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) | 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. | Class II | Open, Classified | |
| Z-0485-2021 | MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation | Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur | Class II | Terminated | |
| Z-2686-2020 | MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients | 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. | Class II | Terminated | |
| Z-2406-2020 | MEVION S250i, MEVION S250; Proton Radiation Treatment System | 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 | Class II | Terminated | |
| Z-0705-2019 | MEVION S250i | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped | Class II | Terminated | |
| Z-2746-2018 | 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 conditions susceptible to treatment by radiation. | 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. | Class II | Terminated | |
| Z-1122-2017 | MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy | An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened | Class II | Terminated | |
| Z-0409-2017 | MEVION S250 Product Usage: Proton Radiation Therapy | Completing Setup Without Program Move Complete Can Cause An Isocenter Error | Class II | Terminated | |
| Z-0410-2017 | MEVION S250 Product Usage: Proton Radiation Therapy System | Recovery of Incorrect Isocenter -operational change | Class II | Terminated | |
| Z-0411-2017 | MEVION S250 Product Usage: Proton Radiation Therapy System | 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 | Class II | Terminated | |
| Z-1529-2016 | MEVION S250 for Proton Radiation Therapy | 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. | Class II | Terminated | |
| Z-0767-2016 | MEVION S250 Radiation therapy system | 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. | Class II | Terminated | |
| Z-0588-2015 | MEVION S250, used for proton radiation therapy. | 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%. | Class II | Terminated | |
| Z-1271-2014 | MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy | Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain