FDA Enforcement
Class II
Ongoing
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
Recall: Z-2693-2024
·
Reported August 28, 2024
Enforcement
- Recall Number
- Z-2693-2024
- Event ID
- 95024
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ion Beam Applications S.A.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 28, 2024
- Initiation Date
- July 10, 2024
- Classification Date
- August 21, 2024
- Address
- Chemin Du Cyclotron 3, Ottignies-Louvain-La-Neuve, N/A, Belgium
Description
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
Reason
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
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).
Distribution
IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Quantity
19 units