Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MEVION S250 Product Usage: Proton Radiation Therapy System Recalled by Mevion Medical Systems, Inc. Due to Software defect:2D projection of contours in Verity. The...

Date: October 20, 2016
Company: Mevion Medical Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mevion Medical Systems, Inc. directly.

Affected Products

MEVION S250 Product Usage: Proton Radiation Therapy System

Quantity: 6 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mevion Medical Systems, Inc.

Mevion Medical Systems, Inc. has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report