# FDA recall Z-2173-2018

> **Ion Beam Applications S.A.** · Class II · device recall initiated 2016-08-07.

## Product

Proteus 235      The PTS 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

## Reason for recall

IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

## Distribution

Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden.  Each country's national Competent Authorities have been informed.

## Key facts

- **Recall number:** Z-2173-2018
- **Recalling firm:** Ion Beam Applications S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-08-07
- **Report date:** 2018-06-20
- **Termination date:** 2020-03-25

- **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-2173-2018

## Citation

> AI Analytics. FDA recall Z-2173-2018. Retrieved 2026-06-11 from https://api.ai-analytics.org/recall/Z-2173-2018. Source: US FDA. Licensed CC0.

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