FDA-Device2017-06-28Class II
Proteus 235
Ion Beam Applications S.A.
Hazard
It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.
Sold states
Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.
Affected count
18 systems ( 10 in the US)
Manufactured in
Chemin du Cyclotron, 3, Louvain La Neuve, Belgium
Products
Proteus 235
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2017Don't want to check this manually?
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