# FDA recall Z-2434-2021

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2021-06-14.

## Product

Proteus 235- 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

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

## Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.

## Key facts

- **Recall number:** Z-2434-2021
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-14
- **Report date:** 2021-09-15

- **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-2434-2021

## Citation

> AI Analytics. FDA recall Z-2434-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2434-2021. Source: US FDA. Licensed CC0.

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