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.
FDA Recall Z-2715-2020 · Posted None
Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2020-07-17
Date Terminated2021-08-30
Product Quantity2 Units
Reason for Recall
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
US: VA OUS: Belgium
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.