FDA Medical Device Recalls (openFDA)
Tecan US, Inc.: 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 number
- Z-1560-2013
- Recalling firm
- Tecan US, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-02-19
- Posted
- 2013-06-19
- Terminated
- 2013-06-20
- 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
- Root cause
- Software change control
- 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.
- Quantity
- 12 units
- Distribution
- Worldwide distribution: US (nationwide) including states of: CA, KY, NC, OH, TX, and WI; and countries of: France, Germany and Italy.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQW
- Firm FEI
- 1037985
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28