Ion Beam Applications Recalls Proteus 235 Proton Therapy System Software
Ion Beam Applications is recalling Proteus 235 Proton Therapy System Legacy Software due to incorrect dose rate calculations for non-zero beam line options.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that could lead to incorrect radiation dosing, which aligns with the rubric for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Ion Beam Applications S.A. is recalling the Proteus 235 Proton Therapy System Legacy Software, version 7.2.7 and higher, for models 110, 112, 113, and 116. The recall involves four units distributed in the United States, specifically in the states of Oklahoma, Illinois, New Jersey, and Washington.
The recall was initiated after internal testing revealed that the software calculates incorrect dose rates when the beam line option is set to anything other than Zero (0). This defect could result in patients receiving an incorrect dose of proton therapy.
Healthcare facilities using the affected software should contact Ion Beam Applications S.A. for further instructions on how to address the issue. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 4
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 (5)
- Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher
- models 110
- 112
- 113
- and 116.
Distribution
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