FDA-Device2014-04-30Class II
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Ion Beam Applications S.A.
Hazard
Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).
Sold states
US Distribution including the states of OK, IL, NJ, and WA.
Affected count
4
Manufactured in
Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, Belgium
Products
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1492-2014Don't want to check this manually?
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