Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Proteus 235 The PTS is a medical device designed to Recalled by Ion Beam Applications S.A. Due to IBA is recalling to provide information through a...
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 The PTS 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: 19 units
Why Was This Recalled?
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
Where Was This Sold?
Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
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