Recall Z-1560-2013— Tecan US, Inc.
Class II · Terminated
Class II FDA medical device recall by Tecan US, Inc., initiated 2013-02-19, terminated 2013-06-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- Tecan US, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-19
- Terminated
- 2013-06-20
- Firm location
- Morrisville, NC, United States
Product 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 for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.