Mevion Medical Systems, Inc. recalls MEVION S250 Product Usage: Proton Radiation Therapy System

Recall date

October 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0411-2017

FDA classification

Class II

Brand / firm

Mevion Medical Systems, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEVION S250 Product Usage: Proton Radiation Therapy System