Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling two Proteus 235 Proton Therapy Systems because users may restart aborted irradiations without selecting correct data.
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: The recall involves a high-risk medical device where a software error could lead to incorrect radiation treatment, representing a risk of harm even though no injuries have been reported.
Plain-English summary
Ion Beam Applications S.A. is recalling two Proteus 235 Proton Therapy Systems, with one unit distributed in the United States and one in France. The recall is due to a software defect that allows users to restart an aborted irradiation without selecting the correct partial irradiation data in specific circumstances.
The affected units are identified by serial numbers SAT.123 (US) and SBF.101 (EU) and run software versions PTS-9.3.1.2 and PTS-9.4.0. The US unit was distributed to Louisiana. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities should contact Ion Beam Applications S.A. for instructions on how to address the software issue. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Proteus 235, Proton Therapy System
- 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 (2)
- Serial Number: SAT.123 (US)
- and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
Distribution
Distributed in 1 state:
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