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 Gantry rotation or proton irradiation can be allowed...

Date: June 27, 2018
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, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver 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: 14

Why Was This Recalled?

Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.

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