Device evidence

device-recall:cfres:184325

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

Official recall number

Z-0485-2021

Evidence summary

Product code: LHN
Recall status: Terminated
Event initiated: October 19, 2020
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0485-2021