Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-0931-2018)

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 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.

Product Classification:

Class II

Date Initiated: October 19, 2017

Date Posted: March 14, 2018

Recall Number: Z-0931-2018

Event ID: 79228

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.

Status: Terminated

Product Quantity: 3

Code Information:

PAT.003 (KR), PAT.006 (US)

Distribution Pattern:

US Distribution to the state of :FL

Voluntary or Mandated:

Voluntary: Firm initiated