# FDA recall Z-2773-2020

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2020-04-21.

## Product

Proteus 235   The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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

Signature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS po

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.

## Key facts

- **Recall number:** Z-2773-2020
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-21
- **Report date:** 2020-08-19
- **Termination date:** 2021-09-01

- **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-2773-2020

## Citation

> AI Analytics. FDA recall Z-2773-2020. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2773-2020. Source: US FDA. Licensed CC0.

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