Medical device recalls Moderate risk

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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