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Ion Beam Applications S.A. recalls Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam f
Recalled May 24, 2017 · FDA recall Z-2097-2017 · Ion Beam Applications S.A
Hazard
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose. · FDA Class II
Units
2
Sold at
FL
Description
A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.
Product
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device 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 →