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Ion Beam Applications S.A. recalls Proteus 235 Proton Therapy System for cancer treatment.
Recalled November 5, 2014 · FDA recall Z-0020-2015 · Ion Beam Applications S.A
Hazard
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel. · FDA Class II
Units
8
Sold at
Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.
Description
While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e., voltage applied between two electrodes in the cyclotron to accelerate protons) may generate a hot spot on a pencil beam position within a tumor, generating a dose that might exceed the prescribed dose on a single voxel.
Product
Proteus 235 Proton Therapy System for cancer treatment.
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →