FDAFDA · Food and drugs·Recall number Z-2693-2024
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
Published August 28, 2024 · Recall initiated: July 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
- Lot
- 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).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.