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 Recalled by Mevion Medical Systems, Inc. Due to Software defect that causes an incorrect dose compensation...

Date: November 10, 2014
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, used for proton radiation therapy.

Quantity: 1

Why Was This Recalled?

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%.

Where Was This Sold?

This product was distributed to 1 state: MO

Affected (1 state)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