FDA-Device2020-07-01Class II

MEVION S250i, MEVION S250; Proton Radiation Treatment System

Mevion Medical Systems, Inc.
Hazard

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

Sold states
Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands
Affected count
8 units
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
MEVION S250i, MEVION S250; Proton Radiation Treatment System

Official notice

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

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