Ion Beam Applications Recalls Proteus Proton Therapy Systems for Software Issues
Ion Beam Applications is recalling Proteus 235 and Proteus ONE proton therapy systems because on-site software installations were not performed consistently with standard operating procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text describes a procedural deviation in software installation without reporting specific injuries, illnesses, or deaths, aligning with a moderate severity rating for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ion Beam Applications S.A. is recalling the Proteus 235 and Proteus ONE proton therapy systems. The recall is being initiated to address on-site software installations that were not performed consistently with IBA standard operating procedures.
The affected units are distributed to facilities in Florida, Virginia, Pennsylvania, Oklahoma, Illinois, New Jersey, Washington, Tennessee, Louisiana, and Texas, as well as in South Korea, Germany, France, the Czech Republic, Italy, Poland, and Sweden. There are 18 units worldwide, with 10 located in the United States.
Specific serial numbers affected by this recall include PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, and SAT.126. The source text does not provide specific instructions for consumers or facility operators regarding immediate actions to take.
The recalled product
- Product
- Proteus 235 and Proteus ONE proton therapy systems
- Manufacturer
- Ion Beam Applications S.A.
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 (17)
- Code/Serial Numbers: PAT.003
- PAT.006
- PAT.107
- PAT.108
- PAT.109
- PAT.110
- PAT.111
- PAT.112
- PAT.113
- PAT.114
- PAT.115
- SAT.116
- SAT.117
- SAT.119
- SAT.120
- SAT.122
- SAT.123 and SAT.126
Distribution
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