BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235, graphite block 8

    Recall: Z-0930-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0930-2018
    Event ID
    79227
    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 14, 2018
    Initiation Date
    October 17, 2017
    Classification Date
    March 8, 2018
    Termination Date
    March 29, 2019
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium

    Description

    Proteus 235, graphite block 8

    Reason

    IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader

    Code Info

    PAT.115, SAT.116

    Distribution

    WA

    Quantity

    3