BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235

    Recall: Z-2592-2017 · Reported June 28, 2017

    Enforcement

    Recall Number
    Z-2592-2017
    Event ID
    77175
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2017
    Initiation Date
    February 9, 2017
    Classification Date
    June 19, 2017
    Termination Date
    July 14, 2023
    Address
    Chemin du Cyclotron, 3, Louvain La Neuve, N/A, Belgium

    Description

    Proteus 235

    Reason

    It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.

    Code Info

    Serial Numbers: PAT.000,PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.111, PAT.112, PAT.113, PAT.114, SAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126

    Distribution

    Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.

    Quantity

    18 systems ( 10 in the US)