MEVION S250 Cl II

Company: Mevion Medical Systems, Inc.
Date of Enforcement Report 11/23/2016
Class lI:

PRODUCT

MEVION S250 Product Usage: Proton Radiation Therapy System
Recall Number Z-0411-2017

REASON
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter.

RECALLING FIRM/MANUFACTURER
Mevion Medical Systems, Inc., Littleton, MA on 11/14/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6

DISTRIBUTION
US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK

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