Mevion Medical Systems, Inc.: FDA recalls

FDA enforcement reports name Mevion Medical Systems, Inc. as the recalling firm in 14 events. The events have 14 product records. The recalls started from 2014 to 2022. All the events are device recalls.

See the 14 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

14 events, newest first.

FDA enforcement events of Mevion Medical Systems, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
1 Feb 2022	Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)	Device	Class II	1	Ongoing
19 Oct 2020	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	Device	Class II	1	Terminated
23 Jun 2020	MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients	Device	Class II	1	Terminated
15 May 2020	MEVION S250i, MEVION S250; Proton Radiation Treatment System	Device	Class II	1	Terminated
1 Oct 2018	MEVION S250i	Device	Class II	1	Terminated
29 Jun 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.	Device	Class II	1	Terminated
16 Dec 2016	MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy	Device	Class II	1	Terminated
31 Oct 2016	MEVION S250 Product Usage: Proton Radiation Therapy	Device	Class II	1	Terminated
21 Oct 2016	MEVION S250 Product Usage: Proton Radiation Therapy System	Device	Class II	1	Terminated
20 Oct 2016	MEVION S250 Product Usage: Proton Radiation Therapy System	Device	Class II	1	Terminated
15 Mar 2016	MEVION S250 for Proton Radiation Therapy	Device	Class II	1	Terminated
18 Nov 2015	MEVION S250 Radiation therapy system	Device	Class II	1	Terminated
10 Nov 2014	MEVION S250, used for proton radiation therapy.	Device	Class II	1	Terminated
5 Mar 2014	MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Mevion Medical Systems, Inc.: events for each product type
Type		Events
Device		14

Mevion Medical Systems, Inc.: events in each class
Class		Events
Class II		14

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Mevion Medical Systems, Inc., by the year that the recall started. The largest year is 2016, with 5 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Mevion Medical Systems, Inc.: FDA recalls. https://recallregister.com/firm/mevion-medical-systems-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Mevion Medical Systems, Inc. have?: Class II: 14 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Mevion Medical Systems, Inc.?: FDA event 89758, which the firm started on 1 Feb 2022. The first product in the record is: Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
How many FDA recalls of Mevion Medical Systems, Inc. have the status Ongoing?: 1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.