BEUDAMED
    FDA Recall Terminated

    Proteus 235 and Proteus ONE proton therapy systems

    Recall: Z-2672-2017 · Initiated May 18, 2016

    Recall

    Recall Number
    Z-2672-2017
    Event Number
    77620
    FEI Number
    3000256071
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 18, 2016
    Terminated
    February 8, 2019
    Address
    Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium

    Description

    Proteus 235 and Proteus ONE proton therapy systems

    Reason

    Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

    Action

    An Urgent Field Safety Notice MID-54097 was mailed to affected customers to inform that IBA plans to deploy a new software by March 2017 to correct the issue. Customers were reminded to follow standard protocol until the software updates are deployed.

    Distribution

    Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden

    Quantity

    18 worldwide and 10, in the U.S.