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Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients wi
Recalled June 12, 2024 · FDA recall Z-1945-2024 · Ion Beam Applications S.A
Hazard
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances · FDA Class II
Units
2 units
Sold at
Worldwide - US Nationwide distribution in the state of Virginia and the country of India.
Description
Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances
Product
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.
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →