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: Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances

Code information: 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

Distribution pattern: Worldwide - US Nationwide distribution in the state of Virginia and the country of India.