Mevion Medical Systems, Inc. recalls MEVION S250 Product Usage: Proton Radiation Therapy System
- Recall date
- October 21, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0410-2017
- FDA classification
- Class II
- Brand / firm
- Mevion Medical Systems, Inc.
- Sold / distributed
- US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,
Why it was recalled
Recovery of Incorrect Isocenter -operational change
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 System
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