Device 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.
Z-2715-2020
Product summary
- Event
- Event 86076
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 Units
- Official record key
device-enforcement:Z-2715-2020
Official wording
Reason: IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Code information: Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
Distribution pattern: US: VA OUS: Belgium
Derived failure modes
-
Unknown
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.