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Mevion Medical Systems, Inc.

Complete recall history across all FDA and CPSC categories — 14 total recalls

Mevion Medical Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Mevion Medical Systems, Inc.

Date Product Reason Class
Feb 1, 2022 Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 3... Malfunction of the hand pendant controlling movement of the therapy couch and... Class II
Oct 19, 2020 MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage:... Treatment beam information disappears on Treatment Console screen while beam ... Class II
Jun 23, 2020 MEVION S250 Proton Radiation Treatment System; intended to deliver proton rad... The perforated screen that divides the inside of the process water tank has ... Class II
May 15, 2020 MEVION S250i, MEVION S250; Proton Radiation Treatment System Couch Correction moves sent after using a 3D CT scan are partially lost if th... Class II
Oct 1, 2018 MEVION S250i Treatment is allowed to continue (via partials) in situations where dDose1 in... Class II
Jun 29, 2018 MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Us... QFix has advised Mevion Medical Systems that they are identifying unauthorize... Class II
Dec 16, 2016 MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy An error can occur causing Delta corrections to be lost when one setup field ... Class II
Oct 31, 2016 MEVION S250 Product Usage: Proton Radiation Therapy Completing Setup Without Program Move Complete Can Cause An Isocenter Error Class II
Oct 21, 2016 MEVION S250 Product Usage: Proton Radiation Therapy System Recovery of Incorrect Isocenter -operational change Class II
Oct 20, 2016 MEVION S250 Product Usage: Proton Radiation Therapy System Software defect:2D projection of contours in Verity. The defect causes struct... Class II
Mar 15, 2016 MEVION S250 for Proton Radiation Therapy Possibility of Gantry Motion with Aperture or Compensator only partially inse... Class II
Nov 18, 2015 MEVION S250 Radiation therapy system The treatment table positioning belt can slip gear positions, resulting in de... Class II
Nov 10, 2014 MEVION S250, used for proton radiation therapy. Software defect that causes an incorrect dose compensation function to be app... Class II
Mar 5, 2014 MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Pr... Geometric positioning error can occur after a rotational correction has been ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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