Medical device recalls Moderate risk

Mevion Medical Systems, Inc. recalls MEVION S250i, MEVION S250; Proton Radiation Treatment System

Recall date
May 15, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2406-2020
FDA classification
Class II
Brand / firm
Mevion Medical Systems, Inc.
Sold / distributed
Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands

Why it was recalled

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

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 S250i, MEVION S250; Proton Radiation Treatment System

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