# FDA recall Z-0934-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2017-12-05.

## Product

Proteus 235, Uniform and Pencil Beam Scanning    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

An accessory (range shifter, ridge filter&) can be improperly inserted in  snout 300x400 with one rail only and the proton therapy system can still  operate.

## Distribution

US Distribution to the states of : MA, FL, VA, PA, OK, TN

## Key facts

- **Recall number:** Z-0934-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-05
- **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-0934-2018

## Citation

> AI Analytics. FDA recall Z-0934-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0934-2018. Source: US FDA. Licensed CC0.

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