BEUDAMED
    FDA Enforcement Class II 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 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1560-2013
    Event ID
    65331
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tecan US, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 26, 2013
    Initiation Date
    February 19, 2013
    Classification Date
    June 19, 2013
    Termination Date
    June 20, 2013
    Address
    9401 Globe Center Drive, Suite 140, Morrisville, NC, 27560, United States

    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

    Code Info

    Instrument Freedom EVO 100 Base Unit: Material number: 10641100, Serial numbers: 1211001569, 1212000203 and 1212000205; Instrument Freedom EVO 100 MCA: Material number: 30020010, Serial number: 1301007643; Instrument Freedom EVO 150 Base Unit: Material number10641150, Serial number: 1301006708; Instrument Freedom EVO 150 MCA: Material number: 30020015, Serial number: 1211007442; Instrument Freedom EVO 150 MCA384: Material number: 30032015, Serial number: 1211011594 and 1109003270; Instrument Freedom EVO 200 Base Unit: Material number: 1641200, Serial number: 1106003923 and 1211011578 and Instrument Freedom EVO 200 MCA: Material number: 30020020, Serial number: 1208007288 and 1208007284.

    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