Class II — Potential Health Hazard

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

Proteus235- Proton Therapy System: to produce and deliver a proton Recalled by Ion Beam Applications S.A. Due to First layer of Uniform Scanning treatment fields is...

Date: April 20, 2022
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

Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

Quantity: 4 units

Why Was This Recalled?

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

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