FDA-Device2024-05-01Class II
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Ion Beam Applications S.A.
Hazard
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Sold states
US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
Affected count
8 units
Manufactured in
Chemin Du Cyclotron 3, N/A, Ottignies-Louvain-La-Neuve, N/A, Belgium
Products
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2024Don't want to check this manually?
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