Events

Safety Alert for td-synergy software version 11.31.c

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by TECHNIDATA S.A.S.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-10-19
  • Event Date Posted
    2012-10-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121019a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: technidata td-synergy software version 11.31.C medical device manufacturer, technidata s.A.S, has initiated a medical device field safety corrective action concerning td-synergy with software version 11.31.C. according to the manufacturer, a software defect has been identified. in certain conditions, results which have not been clinically validated are printed on the cumulative result printouts. the defect only applies to sites using cumulative result reports by department. if the following sequence of events takes place, results which have not been clinically validated, can be printed on the cumulative result printouts. if a request r1 is created for a patient p1 and if this request includes a test t1 where a result has to be validated; if a new request r2 is created for the same patient p1 and if the results of r2 request tests do not need to be clinically validated or are clinically validated before r1 request tests; then the printout of the cumulative report for request r2 results is triggered, including r1 request results with a t1 test which has not been clinically validated. according to the manufacturer, the affected device was distributed in hong kong and the software correction has already been implemented. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 19 october 2012.

Device

td-synergy software version 11.31.c
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: TECHNIDATA TD-Synergy Software Version 11.31.C
  • Manufacturer
    TECHNIDATA S.A.S

Manufacturer

TECHNIDATA S.A.S