The Recall Desk

Manufacturer

Mevion Medical Systems, Inc.

14 recalls in our database name Mevion Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
14
Critical
1
Severe
1
Most recent
2022-04-06

Of the 14 recalls from Mevion Medical Systems, Inc. we have scored against our rubric, 1 (7%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

  • HighFDA (Devices)·Z-0827-2022·2022-04-06

    Hand Pendant Malfunction in Proton Therapy Systems Poses Patient Injury Risk

    Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.

    Product
    Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2021·2020-12-02

    Mevion Proton Radiation Treatment System Recalled for Screen Display Failure

    Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2686-2020·2020-07-29

    Mevion S250 Proton Radiation System Recalled for Sharp Edge Hazard

    Mevion Medical Systems is recalling eight MEVION S250 Proton Radiation Treatment Systems because a sharp edge on a perforated screen poses an injury risk to service personnel.

    Product
    MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2406-2020·2020-07-01

    Mevion Proton Radiation Treatment System Recalled for Software Error

    Mevion Medical Systems is recalling eight MEVION S250i and S250 Proton Radiation Treatment Systems because a software error can cause couch correction moves to be partially lost.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0705-2019·2019-01-16

    Mevion Medical Systems Recalls MEVION S250i Medical Device

    Mevion Medical Systems is recalling one MEVION S250i unit due to a dDose1 interlock trip. Treatment may continue via partials.

    Product
    MEVION S250i
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2746-2018·2018-08-22

    Mevion Medical Systems Recalls MEVION S250 Proton Beam Therapy Systems

    Mevion Medical Systems is recalling seven MEVION S250 and S250i proton beam therapy systems due to unauthorized accessory combinations that may cause patient injury.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2017·2017-02-08

    Mevion S250 Proton Therapy Units Recalled for Data Loss Error

    Mevion Medical Systems is recalling two S250 Proton Radiation Therapy units because a software error can cause Delta corrections to be lost.

    Product
    MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2017·2016-11-23

    Mevion S250 Proton Radiation Therapy System Software Defect Recall

    Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to a software defect that causes 2D contour projections to appear off from their true position.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2017·2016-11-23

    Mevion S250 Proton Radiation Therapy Systems Recalled for Isocenter Recovery Issue

    Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to an operational change affecting the recovery of the incorrect isocenter.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2017·2016-11-23

    Mevion S250 Proton Therapy Systems Recalled for Isocenter Error Risk

    Mevion Medical Systems is recalling six MEVION S250 proton radiation therapy units because completing setup without a program move can cause an isocenter error.

    Product
    MEVION S250 Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1529-2016·2016-04-27

    Mevion S250 Proton Therapy System Recalled for Gantry Motion Hazard

    Mevion Medical Systems is recalling five MEVION S250 proton therapy systems because an aperture may fall out during gantry motion, posing a risk of traumatic injury or death to patients.

    Product
    MEVION S250 for Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0767-2016·2016-02-17

    Mevion S250 Radiation Therapy System Recalled for Positioning Belt Slippage

    Mevion Medical Systems is recalling four MEVION S250 Radiation Therapy Systems because the treatment table positioning belt can slip, causing patient setup deviations.

    Product
    MEVION S250 Radiation therapy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2015·2014-12-17

    Mevion S250 Proton Therapy System Recalled for Software Defect

    Mevion Medical Systems is recalling one MEVION S250 proton therapy system in Missouri due to a software defect that may cause incorrect dose delivery.

    Product
    MEVION S250, used for proton radiation therapy.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1271-2014·2014-04-02

    Mevion S250 Proton Radiation Therapy System Recalled for Positioning Error

    Mevion Medical Systems is recalling the S250 Proton Radiation Therapy System because a geometric positioning error can occur after rotational corrections are applied to treatment fields.

    Product
    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Mevion Medical Systems (United States)

company in Littleton, United States

Country
United States
Founded
2004

Official website

Source: Wikidata (Q104481141), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.