# FDA recall Z-1497-2026

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2026-02-03.

## Product

IBA Proton Therapy System - PROTEUS 235

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1497-2026
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-03
- **Report date:** 2026-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ottignies-Louvain-La-Neuve, N/A, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1497-2026

## Citation

> AI Analytics. FDA recall Z-1497-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1497-2026. Source: US FDA. Licensed CC0.

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