Proteus 235 Proton Beam Device Recalled for Correction Vector Loss
Ion Beam Applications S.A. is recalling three Proteus 235 units because a software defect may cause patients to be treated in the wrong position.
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 defect could lead to incorrect treatment positioning, representing a risk of harm where injury has not yet been reported in the source text.
Plain-English summary
Ion Beam Applications S.A. is recalling three units of the Proteus 235 proton beam device, specifically versions PTS-11.0.1.2 and PTS-11.0.2. The device is designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to radiation treatment.
The recall is due to a defect where the correction vector confirmation message is lost if the access point is changed after the correction vector is sent. As a result, a patient may be treated in the setup position or treatment position instead of the intended corrected position.
The affected units are distributed worldwide, including in the United States (Florida) and in Sweden and The Netherlands. The specific serial numbers for the recalled units are SAT.122 (EU), SAT.132 (EU), and SAT.133 (US). The source text does not specify instructions for consumers or healthcare providers regarding immediate actions to take.
The recalled product
- Product
- Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 3
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)
- Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)
Distribution
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