FDA recall Z-0943-2018

Product

Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 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

The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.

Distribution

Worldwide Distribution: US (nationwide) to: MI only and country of: France.

Key facts

Status

Terminated

Initiation date

2017-11-01

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-0943-2018