# FDA recall Z-1477-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2018-01-26.

## Product

Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

## Reason for recall

When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account when the proton beam is requested. The mismatch between the setpoint and feedback leads to an error message. Depending on user action, two scenarios are possible:    1. The user resumes the treatment field without analyzing the cause for the error message. This may lead to under-irradiation.    2. The user reboots the Scanning Magnets Power Supply Electronic Unit. This may lead to delay in patient treatment and the patient may need to be re-aligned, which leads to an additional X-ray dose.

## Distribution

Consignees in four states: VA, IL, NJ, and WA. One consignee located in Germany.

## Key facts

- **Recall number:** Z-1477-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-26
- **Report date:** 2018-05-02
- **Termination date:** 2020-04-27

- **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-1477-2018

## Citation

> AI Analytics. FDA recall Z-1477-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1477-2018. Source: US FDA. Licensed CC0.

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