BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235

    Recall: Z-1695-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1695-2017
    Event ID
    76696
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 5, 2017
    Initiation Date
    March 9, 2017
    Classification Date
    March 29, 2017
    Termination Date
    March 26, 2019
    Address
    Chemin du Cyclotron, 3, Louvain La Neuve, N/A, Belgium

    Description

    Proteus 235

    Reason

    The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

    Code Info

    Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120

    Distribution

    Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany

    Quantity

    8 worldwide, 4 in U.S.