# FDA recall Z-1945-2024

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2024-05-10.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1945-2024
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-10
- **Report date:** 2024-06-12

- **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-1945-2024

## Citation

> AI Analytics. FDA recall Z-1945-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1945-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*