FDA-Device2018-07-18Class II
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.
Ion Beam Applications S.A.
Hazard
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Sold states
Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
Affected count
3 units
Manufactured in
Chemin du Cyclotron, 3, Louvain La Neuve, Belgium
Products
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2424-2018Don't want to check this manually?
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