Medical device recalls Moderate risk

Mevion Medical Systems, Inc. recalls MEVION S250i

Recall date
October 1, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0705-2019
FDA classification
Class II
Brand / firm
Mevion Medical Systems, Inc.
Sold / distributed
DC

Why it was recalled

Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

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

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