# FDA recall Z-2686-2020

> **Mevion Medical Systems, Inc.** · Class II · device recall initiated 2020-06-23.

## Product

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

## Reason for recall

The perforated screen that divides the inside of the  process water tank has a very sharp edge across  the top of the Heat Exchanger leading to potential injury for servicer.

## Distribution

MO, NJ, OK, FL, OH, DC, Netherlands

## Key facts

- **Recall number:** Z-2686-2020
- **Recalling firm:** Mevion Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-23
- **Report date:** 2020-07-29
- **Termination date:** 2020-12-09

- **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-2686-2020

## Citation

> AI Analytics. FDA recall Z-2686-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2686-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*