BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1212-2015 · Initiated February 2, 2015

    Recall

    Recall Number
    Z-1212-2015
    Event Number
    70545
    Firm
    Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany
    FEI Number
    3006653576
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    February 2, 2015
    Posted
    February 26, 2015
    Terminated
    August 18, 2015

    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.

    Action

    IBA sent an Field Safety Notice dated January 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Please do not use the dose reconstruction function COMPASS 3.1 and 3.1a for DMLC plans from Monaco or Eclipse -11 when the jaws move or MLC leaves reverse during beam on. A correct Version ( COMPASS 3.1b) will be delivered as soon as it is available. The field safety notice including a confirmation of receipt was sent to the affected hospitals; by email and UPS letter on February 2, 2015. Should you have questions or require additional information, please contact the Customer Service Team at South and Middle America, USA and Canada - Phone. +1 901.386.2246 Asia Pacific, Australia and New Zealand - Phone. +86 10 8080 9107 All other countries - Phone. 49 9128 607 - 38

    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