# FDA recall Z-2672-2017

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2016-05-18.

## Product

Proteus 235 and Proteus ONE proton therapy systems

## Reason for recall

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

## Distribution

Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden

## Key facts

- **Recall number:** Z-2672-2017
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-05-18
- **Report date:** 2017-07-12
- **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-2672-2017

## Citation

> AI Analytics. FDA recall Z-2672-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2672-2017. Source: US FDA. Licensed CC0.

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