BEUDAMED
    FDA Recall Terminated

    Proteus 235 Proton Therapy System for cancer treatment.

    Recall: Z-0020-2015 · Initiated March 27, 2014

    Recall

    Recall Number
    Z-0020-2015
    Event Number
    68846
    FEI Number
    3000256071
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 27, 2014
    Posted
    October 29, 2014
    Terminated
    December 10, 2014
    Address
    Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium

    Description

    Proteus 235 Proton Therapy System for cancer treatment.

    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.

    Action

    A User Notice was sent to direct accounts in/about March/April 2014 to notify them of the issue and provide instructions to avoid the identified potential risk to patients.

    Distribution

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

    Quantity

    8