Medical device recalls Moderate risk

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

Recall date
December 16, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1122-2017
FDA classification
Class II
Brand / firm
Mevion Medical Systems, Inc.
Sold / distributed
US Nationwide in the states of OK, NJ

Why it was recalled

An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

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-Proton Radiation Therapy Product Usage: Proton Radiation Therapy

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