BEUDAMED
    FDA Enforcement Class II Terminated

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    Recall: Z-1212-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1212-2015
    Event ID
    70545
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Iba Dosimetry Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2015
    Initiation Date
    February 2, 2015
    Classification Date
    February 26, 2015
    Termination Date
    August 18, 2015
    Address
    Bahnhofstr. 5, N/A, Schwarzenbruck, N/A, N/A, Germany

    Description

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    Reason

    Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or mlc leaves reverse during beam on will not be scaled correctly for all control points.

    Code Info

    Model : SW Version 3.1 Lot or Serial Number : n.a

    Distribution

    Worldwide Distribution - US Distribution to the states of AZ and OK., and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, North and South America, Mexico, Brazil, Venezuela, Colombia, Panama, Asia, China, Japan, Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, Malaysia and Guam.

    Quantity

    124 units