Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2672-2017·Announced 2017-07-12

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.

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 2/5 (Moderate).

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.
Category: Medical Device — Radiation Therapy Equipment
Hazard: software-error
procedural-deviation

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

Distributed in 10 states:

Same manufacturer · Ion Beam Applications S.A.

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