Events

Rappel de Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. 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 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-2013-RN-00649-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-28
  • 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-2013-RN-00649-1
  • 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 has confirmed that, under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a qc or calibrator product from a vista vial. if two samples are dispensed into the same aliquot well, the first sample will always be qc or calibrator from a vista vial. patient sample will never be dispensed into an aliquot well that contains another patient sample.
  • Action
    In the event of an instrument reset, end users are requested to check if there are any QC or calibration tests pending. If there are QC or calibrations pending a software restart is necessary before resuming patient processing. If there is no QC or calibration pending reset or troubleshoot the instrument as per the Operators Guide. A software update will be provided as a permanent fix.

Device

Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical che...
  • Modèle / numéro de série
    Dimension Vista 500 and Dimension Vista 1500 using software versions 3.5.1 and 3.6 - Clinical chemistry analyser. An in vitro diagnostic medical device (IVD)Siemens Material Numbers: 10488224 and 10444802ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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