Mevion Medical Systems, Inc.
Mevion Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 2025, most recent 2026, with 14 FDA device recalls on record.
Top product codes for Mevion Medical Systems, Inc.
FDA recalls by Mevion Medical Systems, Inc.
10 most recent of 14- Z-0827-2022 — Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
- 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
- Z-2686-2020 — MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
- Z-2406-2020 — MEVION S250i, MEVION S250; Proton Radiation Treatment System
- Z-0705-2019 — MEVION S250i
- 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.
- Z-1122-2017 — MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Z-0409-2017 — MEVION S250 Product Usage: Proton Radiation Therapy
- Z-0410-2017 — MEVION S250 Product Usage: Proton Radiation Therapy System
- Z-0411-2017 — MEVION S250 Product Usage: Proton Radiation Therapy System
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mevion Medical Systems, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.