# FDA recall Z-0943-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2017-11-01.

## Product

Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

## Reason for recall

The internal configuration of the electrometers and the Real-Time  control boards of the Dekimo Scanning Controller is not checked before  each patient treatment.

## Distribution

Worldwide Distribution: US (nationwide) to: MI only and country of: France.

## Key facts

- **Recall number:** Z-0943-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-01
- **Report date:** 2018-03-21
- **Termination date:** 2019-03-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2018

## Citation

> AI Analytics. FDA recall Z-0943-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0943-2018. Source: US FDA. Licensed CC0.

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