Medical device recalls Moderate risk

MEVION S250 Proton Radiation Treatment System recalled over laceration hazard

Recall date
June 23, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Mevion Medical Systems, Inc. recalls MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Recall number
Z-2686-2020
FDA classification
Class II
Brand / firm
Mevion Medical Systems, Inc.
Sold / distributed
MO, NJ, OK, FL, OH, DC, Netherlands

Why it was recalled

The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

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 Treatment System; intended to deliver proton radiation treatment to patients

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