# FDA recall Z-2139-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2016-09-16.

## Product

Proteus ONE and Proteus Plus

## Reason for recall

IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.

## Distribution

Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.

## Key facts

- **Recall number:** Z-2139-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-09-16
- **Report date:** 2018-06-20
- **Termination date:** 2019-02-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2018

## Citation

> AI Analytics. FDA recall Z-2139-2018. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/Z-2139-2018. Source: US FDA. Licensed CC0.

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