Ion Beam Applications S.A. recalls The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System…
- Recall date
- April 11, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2284-2018
- FDA classification
- Class II
- Brand / firm
- Ion Beam Applications S.A.
- Sold / distributed
- Units were distributed to Korea and Jacksonville, FL.
Why it was recalled
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
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