Medical device recalls Moderate risk

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

Recall date
October 31, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0409-2017
FDA classification
Class II
Brand / firm
Mevion Medical Systems, Inc.
Sold / distributed
US Nationwide in the states of FL, MO, NJ and OK

Why it was recalled

Completing Setup Without Program Move Complete Can Cause An Isocenter Error

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

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