Class II — Potential Health Hazard

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

Proteus 235 Recalled by Ion Beam Applications S.A. Due to Software issue

Date: December 13, 2016
Company: Ion Beam Applications S.A.
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 Ion Beam Applications S.A. directly.

Affected Products

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Quantity: 6 worldwide and 5 in the U.S.

Why Was This Recalled?

Software issue

Where Was This Sold?

This product was distributed to 5 states: FL, IL, NJ, VA, WA

Affected (5 states)Not affected

About Ion Beam Applications S.A.

Ion Beam Applications S.A. has 36 total recalls tracked by RecallDetector.

Related Recalls

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