FDA-Device2021-08-04Class II
Proteus 235-Proton Therapy System
Ion Beam Applications S.A.
Hazard
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Sold states
FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Affected count
5 US; 8 OUS
Manufactured in
Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, Belgium
Products
Proteus 235-Proton Therapy System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2155-2021Don't want to check this manually?
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