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U.S. Department of Health and Human Services

Class 3 Device Recall TDWorkstation

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  Class 3 Device Recall TDWorkstation see related information
Date Initiated by Firm February 17, 2014
Date Posted March 31, 2014
Recall Status1 Terminated 3 on March 31, 2014
Recall Number Z-1310-2014
Recall Event ID 67628
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product TDWorkstation version 11.01.A or higher. TDWorkstation Evolution.

TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
Code Information version 11.01.A or higher
Recalling Firm/
Manufacturer		 Technidata S.A.
387, Avenue Jean Kuntzmannn
Montbonnot St Martin France
Manufacturer Reason
for Recall		 If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.
FDA Determined
Cause 2		 Software design
Action An email dated 2/17/14 was sent to their customers to inform them about concerns only if their site uses TDWorkstation and TD-Workstation Evolution products that meet all the listed criterias. The criterias are listed in the customer notification letter and it informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the reply form and return it by fax (514) 270-2770 with in 15 days from receiving the customer notification form. Customers that do not respond the reply form, Technidata will consider those customers do not wish to install the correction.
Quantity in Commerce 85 units total (1 unit in US)
Distribution Distributed in the state of PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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