# FDA recall Z-2746-2018

> **Mevion Medical Systems, Inc.** · Class II · device recall initiated 2018-06-29.

## Product

MEVION S250/MEVION S250i Proton Beam Radiation therapy system      Product Usage:  Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

## Reason for recall

QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of  unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.

## Distribution

US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.

## Key facts

- **Recall number:** Z-2746-2018
- **Recalling firm:** Mevion Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-29
- **Report date:** 2018-08-22
- **Termination date:** 2018-10-02

- **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-2746-2018

## Citation

> AI Analytics. FDA recall Z-2746-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2746-2018. Source: US FDA. Licensed CC0.

---

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