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 The internal configuration of the electrometers and the...
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, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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: 3
Why Was This Recalled?
The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ion Beam Applications S.A.
Ion Beam Applications S.A. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report