Company: Mevion Medical Systems, Inc.
Date of Enforcement Report: 7/1/2020
Class II

PRODUCT

MEVION S250i, MEVION S250; Proton Radiation Treatment System

Recall Number: Z-2406-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

Mevion Medical Systems, Inc. on 5/15/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

8 units

DISTRIBUTION

U.S. Nationwide and International