# FDA recall Z-0747-2022

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2022-02-15.

## Product

ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation  Proteus 235

## Reason for recall

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

## Distribution

IL, KS, LA,  FL, MI, OK, PA, NJ,  TN, TX, VA, WA   Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South  Korea, Taiwan, Netherlands,

## Key facts

- **Recall number:** Z-0747-2022
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-15
- **Report date:** 2022-03-16

- **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-0747-2022

## Citation

> AI Analytics. FDA recall Z-0747-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0747-2022. Source: US FDA. Licensed CC0.

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