FDA recall Z-2715-2020

Ion Beam Applications S.A. · Class II · 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.

Reason for recall

IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

Distribution

US: VA OUS: Belgium

Key facts

Status
Terminated
Initiation date
2020-07-17
Report date
2020-08-05
Termination date
2021-08-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louvain-la-neuve, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2715-2020