BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    Recall: Z-2684-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2684-2017
    Event ID
    77621
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2017
    Initiation Date
    December 13, 2016
    Classification Date
    July 4, 2017
    Termination Date
    April 12, 2019
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium

    Description

    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    Reason

    Software issue

    Code Info

    Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003

    Distribution

    Distributed to FL, VA, IL, NJ, WA and South Korea

    Quantity

    6 worldwide and 5 in the U.S.