Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications S.A. is recalling eight Proteus 235 Proton Therapy Systems due to a rare risk of exceeding prescribed radiation doses.
What this means for you
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: The recall involves a risk of exceeding prescribed radiation doses, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Ion Beam Applications S.A. is recalling eight Proteus 235 Proton Therapy Systems used for cancer treatment. The recall involves specific units identified by serial numbers PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, and PAT.119.
The recall was initiated because, while the system is in pencil beam scanning (PBS) treatment mode, low-level radio frequency pulsed dee voltage may occasionally generate a "hot spot" on a pencil beam position within a tumor. This can result in a radiation dose that exceeds the prescribed dose for a single voxel.
The affected units were distributed worldwide, including nationwide in the United States (specifically Pennsylvania, New Jersey, Illinois, Washington, and Tennessee) and in Germany, Italy, and the Czech Republic. The source text does not specify instructions for consumers or patients regarding immediate actions to take.
The recalled product
- Product
- Proteus 235 Proton Therapy System for cancer treatment.
- Manufacturer
- Ion Beam Applications S.A.
- Hazard
- 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 (8)
- PAT.107
- PAT.109
- PAT.112
- PAT.113
- PAT.114
- PAT.115
- PAT.116
- PAT.119.
Distribution
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