FDA recall Z-2406-2020

Product

MEVION S250i, MEVION S250; Proton Radiation Treatment System

Reason for recall

Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

Distribution

Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands

Key facts

Status

Terminated

Initiation date

2020-05-15

Report date

2020-07-01

Termination date

2020-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Littleton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2406-2020