Ion Beam Applications S.A.: Medical Device Recall in 2019 - (Recall #: Z-0698-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Proteus 235 Product Usage: 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 12, 2018

Date Posted: January 16, 2019

Recall Number: Z-0698-2019

Event ID: 81807

Reason for Recall:

There is a risk of detachment of the Compact Gantry Rolling Floor.

Status: Terminated

Product Quantity: 7

Code Information:

SAT.123, SBF.101, SBF.103, SBF.104, SBF.105, SBF.107, SBF.109

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of LA and MI. Foreign distribution to France, Japan, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated