# FDA recall Z-2592-2017

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2017-02-09.

## Product

Proteus 235

## Reason for recall

It has been observed during testing that there could be clinically non-negligible amount of dark current  (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.

## Distribution

Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of:  Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.

## Key facts

- **Recall number:** Z-2592-2017
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-02-09
- **Report date:** 2017-06-28
- **Termination date:** 2023-07-14

- **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-2592-2017

## Citation

> AI Analytics. FDA recall Z-2592-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2592-2017. Source: US FDA. Licensed CC0.

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