Ion Beam Applications S.A.: Medical Device Recall in 2023 - (Recall #: Z-0295-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.

Product Classification:

Class II

Date Initiated: September 18, 2023

Date Posted: November 22, 2023

Recall Number: Z-0295-2024

Event ID: 93293

Reason for Recall:

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

Status: Ongoing

Product Quantity: 5 (US), 9 (OUS)

Code Information:

UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated