FDA recall Z-2686-2020

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2686-2020