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Recall Observatory FDA recall evidence

Device product

Proteus 235 Proton Therapy System for cancer treatment.

Z-0020-2015

March 27, 2014

Class II

Product summary

Firm
Ion Beam Applications S.A.
Event
Event 68846
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-0020-2015

Official wording

Reason: 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.

Code information: PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of PA, NJ, IL, WA, and TN, and the countries of Germany, Italy, and Czech Republic.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.