BEUDAMED
    FDA Recall Terminated

    Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument.

    Recall: Z-1560-2013 · Initiated February 19, 2013

    Recall

    Recall Number
    Z-1560-2013
    Event Number
    65331
    Firm
    Tecan US, Inc.
    FEI Number
    1037985
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    February 19, 2013
    Posted
    June 19, 2013
    Terminated
    June 20, 2013
    Address
    9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560

    Description

    Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument.

    Reason

    WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. If an operator presses "Continue" following a Rich User Prompt and the door has been left open, the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside t

    Action

    The firm, Tecan, sent an "Urgent Field Corrective Action" letter dated February 15, 2013 to its consignees/customers and also contact them by phone February 19, 2013. The letter describes the product, problem and actions to be taken. The customers were instructed to not use Rich User Prompts in Display and Wait mode until TouchTools 3.0 Patch 1 or a higher version has been installed. Tecan is currently testing and releasing a patch that will correct this issue. The patch will be available by the end of February. Tecan will contact you upon its release as installation of the patch is required. If you have any further questions, please contact your local Tecan Helpdesk for assistance or call 919-361-5200 ext 19519.

    Distribution

    Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.

    Quantity

    12 units