BEUDAMED
    FDA Enforcement Class II Terminated

    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

    Recall: Z-1705-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1705-2016
    Event ID
    74087
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Elekta, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    May 12, 2016
    Classification Date
    May 23, 2016
    Termination Date
    July 16, 2021
    Address
    400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States

    Description

    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

    Reason

    If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

    Code Info

    Software iGUIDE 2.1 and 2.2

    Distribution

    IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

    Quantity

    20