# FDA recall Z-0485-2021

> **Mevion Medical Systems, Inc.** · Class II · device recall initiated 2020-10-19.

## Product

MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation

## Reason for recall

Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.

## Key facts

- **Recall number:** Z-0485-2021
- **Recalling firm:** Mevion Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-19
- **Report date:** 2020-12-02
- **Termination date:** 2021-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Littleton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2021

## Citation

> AI Analytics. FDA recall Z-0485-2021. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-0485-2021. Source: US FDA. Licensed CC0.

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