Ion Beam Applications S.A.: Medical Device Recall in 2020 - (Recall #: Z-2715-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Proteus 235 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.

Product Classification:

Class II

Date Initiated: July 17, 2020

Date Posted: August 5, 2020

Recall Number: Z-2715-2020

Event ID: 86076

Reason for Recall:

IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.

Status: Terminated

Product Quantity: 2 Units

Code Information:

Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019

Distribution Pattern:

US: VA OUS: Belgium

Voluntary or Mandated:

Voluntary: Firm initiated