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 for Proton Radiation Therapy Recalled by Mevion Medical Systems, Inc. Due to Possibility of Gantry Motion with Aperture or Compensator...

Date: March 15, 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 for Proton Radiation Therapy

Quantity: 5

Why Was This Recalled?

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.

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