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FDA (Device enforcement)Recalled 2024-07-10class ii

Ion Beam Applications S.A.: 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

Hazard

Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues

Details from the source

Reason for recall: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues Distribution: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden Quantity: 19 units Lot/code info: UDI-DI: (01)05404013801138 Serial Numbers; PAT.108 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.126 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105(US).

UPC codes

05404013801138

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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