BEUDAMED
    FDA Recall Terminated

    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.

    Recall: Z-1707-2014 · Initiated April 15, 2014

    Recall

    Recall Number
    Z-1707-2014
    Event Number
    67926
    Firm
    Brainlab AG Kapellenstrasse 12 Feldkirchen Germany
    FEI Number
    3002619595
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 15, 2014
    Posted
    June 3, 2014
    Terminated
    April 24, 2017

    Description

    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.

    Reason

    When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.

    Action

    Brainlab sent a "FIELD SAFETY NOTICE / PRODUCT NOTIFICATION" letter dated March 13, 2014 was sent to all affected customers. The letter identifies the affected product, problem, and actions to be taken. The letter includes specific instructions to users that are intended to reduce the likelihood of similar events occurring when using ExacTrac software version 5.5.5. The letter further states that Brainlab will be providing a software update to all customers. Brainlab will contact all customers to arrange for the software update within the following 6 months. Customers with any questions about this issue can contact Brainlab at 800-597-5911 or via e-mail at [email protected].

    Distribution

    Worldwide Distribution - US Nationwide in the states of AZ, AR, CA, FL, KY, MA, NE, NY, TN, TX and the countries of Argentina, Australia, Brazil, Finland, India, Japan, Netherlands, Oman, Russia, and Taiwan

    Quantity

    40 systems (worldwide)