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 and S250i Proton Therapy Systems hand pendant (P/N Recalled by Mevion Medical Systems, Inc. Due to Malfunction of the hand pendant controlling movement of...

Date: February 1, 2022
Company: Mevion Medical Systems, Inc.
Status: Ongoing
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 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

Quantity: 39 (36 US, 3 OUS)

Why Was This Recalled?

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.

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