BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

    Recall: Z-1492-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1492-2014
    Event ID
    67678
    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 30, 2014
    Initiation Date
    December 4, 2013
    Classification Date
    April 24, 2014
    Termination Date
    June 12, 2014
    Address
    Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, N/A, Belgium

    Description

    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

    Reason

    Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculation in case of beam line option other than Zero (0).

    Code Info

    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116.

    Distribution

    US Distribution including the states of OK, IL, NJ, and WA.

    Quantity

    4