Rappel de Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Healthcare Diagnostics, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Calculator/data processing module, for clinical use - Product Code JQP
  • Cause
    Under extremely rare circumstances, a patient result that had been previously disabled may be released without proper review. (disabled test in centralink system or aptio system may become enabled in centralink system.).
  • Action
    The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated October 23, 2013 to its customers. The firm also sent a follow-up letter dated October 30, 2013. The letter describes the product, problem and actions to be taken. The customers were instructed Until a service visit is scheduled, do the following: Instruct the laboratory staff to recognize this sequence of events and Ensure that whenever the operator disables a method on an Aptio system or a CentraLinksystem and replenishes reagent for that method, the operator then confirms that the method remains disabled in the CentraLink system or disables it again. The operator must allow up to five minutes to verify that the test remains disabled. In addition, the customers were instructed tocomplete and return the FIELD CORRECTION EFFECTIVENESS CHECK response form via fax to Siemens Healthcare Diagnostics Customer Care Center at 800-441-9250, and to retain this letter with your laboratory records, and forward this letter to those who may have received this product. After a service visit is performed and an interim solution is implemented, the laboratory staff will be trained on this update to understand the minor but necessary changes in the workflow. If you have any questions, please contact your Siemens Customer Care Center at 800-441-9250 or your local Siemens representative.


  • Modèle / numéro de série
    CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 Catalog Numbers: 10810210, 10811596, 10814296, 10814298, 10814877, 10815474.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US Distribution in the states of: MN, NJ, and NV.
  • Description du dispositif
    Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 || The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
  • Manufacturer


  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
  • Source