Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium is recalling Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a due to IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Recommended Action
Per FDA guidance
An Urgent Medical Device Correction notification will be communicated to all impacted IBA customers (users of the device), starting July 23, 2020. This letter instructs the customer: If this situation were to occur, it is recommended to complete the aborted treatment in Standalone Mode (please refer to the steps described in annex I and to the part Using adaPTdeliver in Standalone Mode of the Proton Therapy System Clinical Users Guide). IBA will modify the software to remove conditions that make impossible to load the plan to complete the aborted treatment. The solution will be deployed on your site by June 30, 2022.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
VA
Page updated: Jan 10, 2026