BEUDAMED
    FDA Enforcement Class II Terminated

    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

    Recall: Z-0168-2015 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0168-2015
    Event ID
    69583
    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
    November 12, 2014
    Initiation Date
    September 25, 2014
    Classification Date
    November 4, 2014
    Termination Date
    January 26, 2015
    Address
    Bahnhofstr. 5, N/A, Schwarzenbruck, N/A, N/A, Germany

    Description

    COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological

    Reason

    Error in the software. A deviation between reconstructed and planned dose distribution may not be detected prior to treatment and this can result in an over or under-estimation of the pretreatment delivered dose.

    Code Info

    N/A

    Distribution

    Worldwide Distribution-Distributed in the US including Guam and the countries of Germany, Austria, France, UK, Poland, Finland, The Netherlands, Spain, Turkey, Russia, and South Africa, Algeria, Mexico, Brazil, Venezuela, Columbia, Panama, China, Japan Philippines, Korea, India, Singapore, Thailand, Taiwan, Hong Kong, and Malaysia.

    Quantity

    124 units