Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-0943-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 1, 2017

Date Posted: March 21, 2018

Recall Number: Z-0943-2018

Event ID: 79229

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.

Status: Terminated

Product Quantity: 3

Code Information:

SBF.101 (EU), SBF.105 (US)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated