BEUDAMED
    FDA Enforcement Class II Terminated

    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    Recall: Z-0456-2014 · Reported December 18, 2013

    Enforcement

    Recall Number
    Z-0456-2014
    Event ID
    66808
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Iba Dosimetry Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 18, 2013
    Initiation Date
    August 20, 2013
    Classification Date
    December 6, 2013
    Termination Date
    February 24, 2014
    Address
    Bahnhofstr. 5, Schwarzenbruck, N/A, Germany

    Description

    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    Reason

    The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.

    Code Info

    SW Version 3.0. Catalong Number CS10-100

    Distribution

    Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany) Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.

    Quantity

    33 units