Events

Rappel de Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System (RMS) Dimension RxL Max HM

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-01114-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-17
  • 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-01114-1
  • 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 rms refrigeration compressors that are missing the safety cover on the electrical termination block. the exposed electrical hazard on the electrical termination block is located directly behind the rms waste container. the absence of the safety cover results in a potential electrical hazard to the operator. this issue does not impact patient results.
  • Action
    Siemens is providing a safety warning to be placed on the machine as an interim measure. A service engineer will be inspecting all units and installing a cover where required.

Device

Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System ...
  • Modèle / numéro de série
    Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System (RMS) Dimension RxL Max HMCatalogue Numbers: 10472176, 10444833 and 10444829ARTG Number: 174699An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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