BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Recall: Z-0938-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0938-2018
    Event ID
    79230
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    November 17, 2017
    Classification Date
    March 9, 2018
    Termination Date
    June 14, 2021
    Address
    Chemin du Cyclotron, 3, Louvain La Neuve, N/A, Belgium

    Description

    Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    Reason

    There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.

    Code Info

    PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)

    Distribution

    Nationally

    Quantity

    37