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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