Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling two Proteus 235 proton therapy systems because aborted irradiations cannot be resumed due to a software loading issue.
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 is classified as FDA Class II. Per the rubric, this falls under 'High' severity as it involves a risk-of-harm product where specific injury reports are not detailed in the source text, but the defect prevents the completion of medical treatment.
Plain-English summary
Ion Beam Applications S.A. is recalling two units of the Proteus 235 Proton Therapy System (brand names: Proteus Plus and Proteus ONE). The device is a medical system 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 was initiated because the manufacturer became aware of an issue preventing the resumption of aborted irradiations. Specifically, the plan to complete the treatment cannot be loaded. The affected units are identified by serial number SAT.140 (manufactured May 2019) and SBF.112 (manufactured October 2019). Distribution was limited to the United States (Virginia) and Belgium.
Healthcare facilities and consumers should contact Ion Beam Applications S.A. for instructions on how to address this issue. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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
- 2
Distribution
Distributed in 1 state:
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