BEUDAMED
    FDA Recall Terminated

    Proteus 235

    Recall: Z-1695-2017 · Initiated March 9, 2017

    Recall

    Recall Number
    Z-1695-2017
    Event Number
    76696
    FEI Number
    3000256071
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 9, 2017
    Posted
    March 23, 2017
    Terminated
    March 26, 2019
    Address
    Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium

    Description

    Proteus 235

    Reason

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

    Action

    A Field Safety Notice was mailed or handed to affected customers to inform them of the issue. The notice provides information on the issue, the risk for the patient and user and actions to be taken before starting gantry rotation. Corrective action developed by IBA are detailed.

    Distribution

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

    Quantity

    8 worldwide, 4 in U.S.