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
- Recall Number
- Z-2715-2020
- Event Number
- 86076
- Firm
- Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium
- FEI Number
- 3000256071
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- July 17, 2020
- Terminated
- August 30, 2021
Description
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.
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
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.
US: VA OUS: Belgium
2 Units