FDA-Device2022-03-16Class II
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Ion Beam Applications S.A.
Hazard
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
Sold states
IL, KS, LA, FL, MI, OK, PA, NJ, TN, TX, VA, WA Foreign: Belgium, England, Germany, France, Czech Republic, Italy, Poland, Russia, Spain, Sweden, South Korea, Taiwan, Netherlands,
Affected count
15 units US; 22 units OUS
Manufactured in
Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, Belgium
Products
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0747-2022Don't want to check this manually?
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