Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions,…
- Recall date
- July 8, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3089-2024
- FDA classification
- Class II
- Brand / firm
- Ion Beam Applications S.A.
- Sold / distributed
- Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.
Why it was recalled
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
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