Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ProteusPLUS and ProteusONE- designed to produce and deliver a proton Recalled by Ion Beam Applications S.A. Due to When resuming from a beam pause, the Proton...
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
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Quantity: 15 units US; 22 units OUS
Why Was This Recalled?
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
Where Was This Sold?
This product was distributed to 12 states: FL, IL, KS, LA, MI, NJ, OK, PA, TN, TX, VA, WA
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