Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-0934-2018)

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, 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.

Product Classification:

Class II

Date Initiated: December 5, 2017

Date Posted: March 21, 2018

Recall Number: Z-0934-2018

Event ID: 79231

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.

Status: Terminated

Product Quantity: 14

Code Information:

PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), SAT.119 (US).

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated