Class II — Potential Health Hazard

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

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Recalled by Ion Beam Applications S.A. Due to Safety Parameters Verification Mechanisms can be deactivated in...

Date: July 8, 2024
Company: Ion Beam Applications S.A.
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 Ion Beam Applications S.A. directly.

Affected Products

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

Quantity: 35 units

Why Was This Recalled?

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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