Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling Proteus 235 proton therapy systems because the gantry can rotate even if the snout is not properly locked.
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 with a mechanical defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ion Beam Applications S.A. is recalling the Proteus 235 Proton Therapy System. The recall involves 8 units worldwide, with 4 located in the United States. The affected units are distributed in Massachusetts, Florida, Virginia, and Tennessee, as well as in China, South Korea, France, and Germany.
The recall is being issued because the Proton Therapy System can allow gantry rotation even if the snout is not properly locked. This defect presents a risk of harm to patients or operators if the equipment is used in this state.
Healthcare facilities that have purchased or received these devices should contact Ion Beam Applications S.A. for instructions on how to address the issue. The specific serial numbers affected are PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, and SAT.120.
The recalled product
- Product
- Proteus 235
- 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 (8)
- Serial numbers: PAT.000
- PAT.001
- PAT.003
- PAT.006
- PAT.108
- PAT.111
- SAT.119
- SAT.120
Distribution
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