# FDA recall Z-2155-2021

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2021-05-26.

## Product

Proteus 235-Proton Therapy System

## Reason for recall

if the user forgets to select the trigger  input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

## Distribution

FL,  PA, TN, TX, VA    Foreign:   Germany, Italy, Russia, Sweden , India, Netherlands

## Key facts

- **Recall number:** Z-2155-2021
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-26
- **Report date:** 2021-08-04

- **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-2155-2021

## Citation

> AI Analytics. FDA recall Z-2155-2021. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2155-2021. Source: US FDA. Licensed CC0.

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