# FDA recall Z-1205-2022

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2022-04-20.

## Product

Proteus235- Proton Therapy System:  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

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

## Distribution

Worldwide distribution - US Nationwide distribution in the states of IL, VA, WA and the country of Germany.

## Key facts

- **Recall number:** Z-1205-2022
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-20
- **Report date:** 2022-06-08

- **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-1205-2022

## Citation

> AI Analytics. FDA recall Z-1205-2022. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1205-2022. Source: US FDA. Licensed CC0.

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