# FDA recall Z-0938-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2017-11-17.

## Product

Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

## Reason for recall

There is a risk of misalignment of the patient when using treatment  plans with multiple isocenters.

## Distribution

Nationally

## Key facts

- **Recall number:** Z-0938-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-17
- **Report date:** 2018-03-21
- **Termination date:** 2021-06-14

- **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-0938-2018

## Citation

> AI Analytics. FDA recall Z-0938-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0938-2018. Source: US FDA. Licensed CC0.

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