# FDA recall Z-2284-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2016-04-11.

## Product

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)     Proteus 235, Beam Management System (PBS)

## Reason for recall

IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.

## Distribution

Units were distributed to Korea and Jacksonville, FL.

## Key facts

- **Recall number:** Z-2284-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-04-11
- **Report date:** 2018-07-04
- **Termination date:** 2020-03-25

- **Voluntary/Mandated:** —
- **Location:** Louvain La Neuve, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2284-2018

## Citation

> AI Analytics. FDA recall Z-2284-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2284-2018. Source: US FDA. Licensed CC0.

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