FDA recall Z-0931-2018

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

Product

Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Reason for recall

Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.

Distribution

US Distribution to the state of :FL

Key facts

Status
Terminated
Initiation date
2017-10-19
Report date
2018-03-14
Termination date
2019-04-02
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-0931-2018