Events

Alerte De Sécurité sur td-synergy software version 11.31.c

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par TECHNIDATA S.A.S.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-10-19
  • Date de publication de l'événement
    2012-10-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121019a.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: TECHNIDATA TD-Synergy Software Version 11.31.C
  • Manufacturer
    TECHNIDATA S.A.S

Manufacturer

TECHNIDATA S.A.S