FDA recall Z-0934-2018

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

Product

Proteus 235, Uniform and Pencil Beam Scanning 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

An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.

Distribution

US Distribution to the states of : MA, FL, VA, PA, OK, TN

Key facts

Status
Terminated
Initiation date
2017-12-05
Report date
2018-03-21
Termination date
2019-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louvain La Neuve, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0934-2018