BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0168-2015 · Initiated September 25, 2014

    Recall

    Recall Number
    Z-0168-2015
    Event Number
    69583
    Firm
    Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany
    FEI Number
    3006653576
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 25, 2014
    Posted
    November 4, 2014
    Terminated
    January 26, 2015

    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.

    Action

    The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on 09/25/2014.

    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