Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is voluntarily recalling two Proteus 235 Proton Therapy Systems to address a software issue and reduce associated risks.
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 (proton therapy system) where a software issue presents a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a High severity score.
Plain-English summary
Ion Beam Applications S.A. is conducting a voluntary recall of two Proteus 235 Proton Therapy Systems, also known by the brand names Proteus Plus and Proteus ONE. The recall is being conducted to address a software issue within the Beam Management System (PBS) and to reduce the risk related to this issue.
The affected units were distributed to Korea and Jacksonville, FL. The specific units involved are identified by codes PAT.003 and PAT.006. The source text does not specify the exact nature of the software defect or the specific clinical risks associated with it, other than the general statement that the recall is intended to reduce risk.
Consumers and healthcare facilities with these specific units should contact Ion Beam Applications S.A. for further instructions on how to address the software issue.
The recalled product
- Product
- The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
- Manufacturer
- Ion Beam Applications S.A.
- Hazard
- Affected units
- 2
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 (1)
- PAT.003 and PAT.006
Distribution
Distribution scope not specified by the agency.
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