# FDA recall Z-2406-2020

> **Mevion Medical Systems, Inc.** · Class II · device recall initiated 2020-05-15.

## Product

MEVION S250i, MEVION S250; Proton Radiation Treatment System

## Reason for recall

Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

## Distribution

Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands

## Key facts

- **Recall number:** Z-2406-2020
- **Recalling firm:** Mevion Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-15
- **Report date:** 2020-07-01
- **Termination date:** 2020-12-11

- **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-2406-2020

## Citation

> AI Analytics. FDA recall Z-2406-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2406-2020. Source: US FDA. Licensed CC0.

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