Ion Beam Applications S.A. recalls Proteus 235 and Proteus ONE proton therapy systems
- Recall date
- May 18, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2672-2017
- FDA classification
- Class II
- Brand / firm
- Ion Beam Applications S.A.
- Sold / distributed
- Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Why it was recalled
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Proteus 235 and Proteus ONE proton therapy systems
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