TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connecte

FDA device recall Z-1310-2014 · posted 2014-03-31 · Terminated

Recall details

Recalling firm

Technidata S.A.

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

85 units total (1 unit in US)

Distribution

Distributed in the state of PA.

Date initiated

2014-02-17

Date posted

2014-03-31

Date terminated

2014-03-31

Location

Montbonnot St Martin, France