Events

Rappel de syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (IVD)

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 Healthcare Pty Ltd.

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-2015-RN-00842-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-31
  • 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-2015-RN-00842-1
  • 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 has identified the following five system software feature issues with the syngo lab data manager:- - result unit conversion;- quality control processing;- virus protection; - system performance degradation; and- order received from lis is rejected.If an issue were to exist the user would be made aware via system alerts, quality control processing status or standard syngo ldm rule validation.
  • Action
    Siemens is providing system configuration modifications to correct the identified issues. Siemens is not recommending a look back of previously generated results.

Device

syngo Lab Data Manager with software version VA12B. (Software used to supplement operational func...
  • Modèle / numéro de série
    syngo Lab Data Manager with software version VA12B. (Software used to supplement operational functions). An in vitro diagnostic medical device (IVD) ARTG Number: 224616
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA