Proton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation
IBA Proton Therapy System (PROTEUS 235) units recalled due to safety parameter failures that could prevent proper radiation control, risking unintended radiation exposure during cancer treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a serious hazard—potential unintended radiation exposure during cancer treatment. However, the source text does not report any illnesses, injuries, or deaths. Per the rubric, theoretical hazards without reported harm are scored at most 3 (High).
Plain-English summary
Ion Beam Applications S.A. is recalling eight units of the IBA Proton Therapy System—PROTEUS 235 (PTS-10, PTS-11, and PTS-12 versions)—due to a risk of patient mistreatment. When certain safety parameters are out of tolerance, the system may fail to prevent proper irradiation, potentially exposing patients to unintended radiation during treatment.
The affected units were distributed nationwide to facilities in Arkansas, Florida, Louisiana, Kansas, Michigan, Texas, and Virginia. Specific affected units are identified by serial numbers SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, and SBF.135.
Healthcare facilities currently using these systems should contact Ion Beam Applications S.A. for guidance. The FDA classified this as a Class II recall, which indicates a serious safety concern.
The recalled product
- Product
- IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- PTS-10 versions
- PTS-11 versions
- and PTS-12 versions. UDI-DI: 05404013801138
- Serial Numbers: SAT.123
- SAT.126
- SAT.133
- SAT.140
- SBF.105
- SBF.113
- SBF.128
- SBF.135. All configurations.
Distribution
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