Ion Beam Applications S.A.: Medical Device Recall in 2024 - (Recall #: Z-1945-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

IBA Proton Therapy System - PROTEUS 235 - 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 10, 2024

Date Posted: June 12, 2024

Recall Number: Z-1945-2024

Event ID: 94576

Reason for Recall:

Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI: SAT140: (01)05404013814015(11)190507(21)SAT140 SAT136: (01)05404013801138(11)201105(21)SAT136 Serial Numbers: SAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of Virginia and the country of India.

Voluntary or Mandated:

Voluntary: Firm initiated