FDA recall Z-0485-2021

Product

MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation

Reason for recall

Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-10-19

Report date

2020-12-02

Termination date

2021-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Littleton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2021