RegWardenFDA facility compliance records
Facility

MEVION MEDICAL SYSTEMS, INC.

14 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 2 recalls; 2015: 1 recalls; 2016: 5 recalls; 2017: 1 inspections; 2018: 2 recalls; 2020: 3 recalls, 1 inspections; 2022: 1 recalls2’141’155’161’172’18’194’20’211’22’23’24’25’26
  • Recalls (14)
  • Inspections (2)

Devices registered here (1)

  • System, Radiation Therapy, Charged-Particle, Medical
    Product code LHN (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

20221 record
  • Class IIOngoing2022-02-01
    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.
20203 records
  • Class IITerminated2020-10-19
    Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
  • Class IITerminated2020-06-23
    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 IITerminated2020-05-15
    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
20182 records
  • Class IITerminated2018-10-01
    Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
  • Class IITerminated2018-06-29
    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) acc…
20165 records
  • Class IITerminated2016-12-16
    An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
  • Class IITerminated2016-10-31
    Completing Setup Without Program Move Complete Can Cause An Isocenter Error
  • Class IITerminated2016-10-21
    Recovery of Incorrect Isocenter -operational change
  • Class IITerminated2016-10-20
    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 IITerminated2016-03-15
    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.
20151 record
  • Class IITerminated2015-11-18
    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.
20142 records
  • Class IITerminated2014-11-10
    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 IITerminated2014-03-05
    Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

FDA inspections (2)

  • NAI2020-03-05
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
  • VAI2017-03-30
    Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEVION MEDICAL SYSTEMS, INC. (FEI 3007087027) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007087027-mevion-medical-systems-inc/

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