Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling three Proteus 235 proton therapy systems because the internal configuration of electrometers and control boards is not checked before each patient treatment.
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. The hazard involves a failure to verify critical safety configurations before radiation treatment, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ion Beam Applications S.A. is recalling three units of the Proteus 235 Proton Therapy System, including the Proteus Plus and Proteus ONE brands. The affected software versions are PTS-9.4.X and PTS-10.0.1.1. These medical devices are designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to radiation therapy.
The recall is due to a defect where the internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. The affected units were distributed in the United States (specifically Michigan) and France.
Healthcare facilities and consumers should contact Ion Beam Applications S.A. for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 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…
- 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 (2)
- SBF.101 (EU)
- SBF.105 (US)
Distribution
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