Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients wi…
- Recall date
- July 10, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2693-2024
- FDA classification
- Class II
- Brand / firm
- Ion Beam Applications S.A.
- Sold / distributed
- IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Why it was recalled
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
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- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
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