FDA-Device2017-07-12Class II
Proteus 235 and Proteus ONE proton therapy systems
Ion Beam Applications S.A.
Hazard
Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Sold states
Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden
Affected count
18 worldwide and 10, in the U.S.
Manufactured in
Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, Belgium
Products
Proteus 235 and Proteus ONE proton therapy systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2672-2017Don't want to check this manually?
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