FDAFebruary 3, 2026device
IBA Proton Therapy System - PROTEUS 235
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.
What to do
FDA enforcement status: Ongoing
Brands named
ion beam applicationsionion beam
UPCs
05404013801138
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-612024-09-23
- FDAIBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation2024-07-10
- FDAIBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions2024-07-08
- FDAIBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.2024-05-10
- FDAIBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.2024-03-04
- FDAION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA2023-09-29
- FDAION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA2023-09-29
- FDARestore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA2023-09-29
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