FDAFDA · Food and drugs·Recall number Z-1945-2024
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 June 12, 2024 · Recall initiated: May 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
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
- Lot
- UDI: SAT140: (01)05404013814015(11)190507(21)SAT140 SAT136: (01)05404013801138(11)201105(21)SAT136 Serial Numbers: SAT136, SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions, with C230 accelerator
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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