# FDA recall Z-0466-2022

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2021-11-29.

## Product

Proteus 235; Version: PTS-8 versions before PTS-8.7.2

## Reason for recall

Proton Therapy System (PTS) software can be  started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using  test  processes without notifying the clinical  user. If the versions of the processes are different between both environments, this could  have an impact on patient treatments.

## Distribution

IN USA: VA, OK, NJ, TN  OUS: Czech Republic.

## Key facts

- **Recall number:** Z-0466-2022
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-29
- **Report date:** 2022-01-19
- **Termination date:** 2024-02-20

- **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-0466-2022

## Citation

> AI Analytics. FDA recall Z-0466-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0466-2022. Source: US FDA. Licensed CC0.

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