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Mevion Medical Systems Recalls
14 recalls on record · April 2, 2014 to April 6, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 6, 2022Medical DevicesFDA
Mevion Medical Systems, Inc. recalls Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Hazard: 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.
December 2, 2020Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treat
Hazard: Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
July 29, 2020Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Hazard: 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.
July 1, 2020Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250i, MEVION S250; Proton Radiation Treatment System
Hazard: 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
January 16, 2019Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250i
Hazard: Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
August 22, 2018Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiati
Hazard: 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.
February 8, 2017Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Hazard: An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
November 23, 2016Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250 Product Usage: Proton Radiation Therapy System
Hazard: 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
November 23, 2016Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250 Product Usage: Proton Radiation Therapy System
Hazard: Recovery of Incorrect Isocenter -operational change
November 23, 2016Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250 Product Usage: Proton Radiation Therapy
Hazard: Completing Setup Without Program Move Complete Can Cause An Isocenter Error
April 27, 2016Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250 for Proton Radiation Therapy
Hazard: 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.
February 17, 2016Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250 Radiation therapy system
Hazard: 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.
December 17, 2014Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250, used for proton radiation therapy.
Hazard: 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%.
April 2, 2014Medical DevicesFDA
Mevion Medical Systems, Inc. recalls MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: P
Hazard: Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields