# FDA recall Z-2424-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2018-05-16.

## Product

Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2    Product Usage:  A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

## Reason for recall

Correction vector confirmation  message is lost if access point is changed after sending the correction vector.  As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

## Distribution

Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands

## Key facts

- **Recall number:** Z-2424-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-16
- **Report date:** 2018-07-18
- **Termination date:** 2018-10-16

- **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-2424-2018

## Citation

> AI Analytics. FDA recall Z-2424-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2424-2018. Source: US FDA. Licensed CC0.

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