Z-2693-2024 Class II Ongoing
FDA device recall Z-2693-2024 was initiated by Ion Beam Applications S.A. on July 10, 2024 and is designated Class II. Reason for recall: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues The recall status is ongoing. Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2024
- Initiation Date
- July 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product 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 for Recall
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
Distribution Pattern
IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Code Information
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).