BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235 Proton Therapy System for cancer treatment.

    Recall: Z-0020-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0020-2015
    Event ID
    68846
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    March 27, 2014
    Classification Date
    October 29, 2014
    Termination Date
    December 10, 2014
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, 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.

    Code Info

    PAT.107, PAT.109, PAT.112, PAT.113, PAT.114, PAT.115, PAT.116, PAT.119.

    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