Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Proteus 235-Proton Therapy System Recalled by Ion Beam Applications S.A. Due to if the user forgets to select the trigger...
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-Proton Therapy System
Quantity: 5 US; 8 OUS
Why Was This Recalled?
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Where Was This Sold?
This product was distributed to 5 states: FL, PA, TN, TX, VA
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