Events

Rappel de CentraLink Data Management System V14 (Analyser software for in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10811600, 10811601, 10814296, 10814298, 10814877, 10814880, 10814881, 10811741, 10811742, 10811743, 10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10815474 & 10811596ARTG Number: 224615

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd Diagnostics Division.

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
    Recall
  • ID de l'événement
    RC-2014-RN-00926-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-22
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00926-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Siemens healthcare diagnostics has identified a task scheduler issue with the centralink data management system, software version 14. the issue may cause the software to stop executing commands, including uploading validated results to the lis. the issue is related to an internal software timer that overflows after 24 days. automated rules triggered by task schedulers or by actions in the centralink user interface may also be affected. the specific consequences of discontinued command execution will vary:1) automated rules will stop running. results may be released to the lis that should have been held based on the automated rules.2) tasks to upload results and download orders to/from the lis will stop running causing a delay in test processing. 3) data in memory may not be updated causing data displayed on reports to not be up to date. however, the lis information would be correct.4) a database backup may not occur when scheduled.
  • Action
    Siemens Healthcare Diagnostics is advising customers to log out of user sessions and restart the CentraLink services and translators as soon as it is convenient. Then periodically (more often than every 24 days) using the procedure provided to restart the CentraLink Data Management System. Siemens is currently investigating further corrective actions. This action has been closed-out on 18/08/2016.

Device

CentraLink Data Management System V14 (Analyser software for in vitro diagnostic medical device (...
  • Modèle / numéro de série
    CentraLink Data Management System V14 (Analyser software for in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10811600, 10811601, 10814296, 10814298, 10814877, 10814880, 10814881, 10811741, 10811742, 10811743, 10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10815474 & 10811596ARTG Number: 224615
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA