Ion Beam Applications S.A.: Medical Device Recall in 2024 - (Recall #: Z-1603-2024)

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, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

Product Classification:

Class II

Date Initiated: March 4, 2024

Date Posted: May 1, 2024

Recall Number: Z-1603-2024

Event ID: 94297

Reason for Recall:

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

Status: Ongoing

Product Quantity: 8 units

Code Information:

PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.

Distribution Pattern:

US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.

Voluntary or Mandated:

Voluntary: Firm initiated