Ion Beam Applications S.A.: 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

Hazard

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

Details from the source

Reason for recall: Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are outside of the defined tolerances Distribution: Worldwide - US Nationwide distribution in the state of Virginia and the country of India. Quantity: 2 units Lot/code info: 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

UPC codes

05404013814015, 05404013801138

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.