# FDA recall Z-0827-2022

> **Mevion Medical Systems, Inc.** · Class II · device recall initiated 2022-02-01.

## Product

Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)

## Reason for recall

Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.

## Distribution

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

## Key facts

- **Recall number:** Z-0827-2022
- **Recalling firm:** Mevion Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-01
- **Report date:** 2022-04-06

- **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-0827-2022

## Citation

> AI Analytics. FDA recall Z-0827-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0827-2022. Source: US FDA. Licensed CC0.

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