Ion Beam Applications S.A.: Medical Device Recall in 2026 - (Recall #: Z-1497-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

IBA Proton Therapy System - PROTEUS 235

Product Classification:

Class II

Date Initiated: February 3, 2026

Date Posted: March 18, 2026

Recall Number: Z-1497-2026

Event ID: 98364

Reason for Recall:

It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used.

Status: Ongoing

Product Quantity: 4 units (1 US, 3 OUS)

Code Information:

PROTEUS 235; UDI-DI: 05404013801138; Serial Numbers: SBF103 (JP), SBF124 (EU), SBF133 (US), SBF140 (EU)

Distribution Pattern:

Worldwide - US Nationwide distribution in the state of FL and the countries of Italy and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated