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