Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-2424-2018)

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, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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: May 16, 2018

Date Posted: July 18, 2018

Recall Number: Z-2424-2018

Event ID: 80298

Reason for Recall:

Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

Status: Terminated

Product Quantity: 3 units

Code Information:

Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated