Events

Rappel de Biograph mCT and Biograph mCT Flow

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-2016-RN-01650-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-23
  • 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-2016-RN-01650-1
  • 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
    An issue has been identified that the light marker windows used for the positioning laser and integrated into the front cover of the biograph mct or biograph mct flow system may loosen and potentially drop out. in this case, there is a risk that a person could touch the electrical or rotating parts of the gantry in the unlikely event that they reach through the window opening. this could result in a serious injury such as electrical shock or physical harm. there have not been any reports of complaints regarding this issue.
  • Action
    Siemens is advising users to conduct a visual inspection of their Biograph mCT or Biograph mCT Flow and that in the event that the light market window is missing or loose, they should not use the Biograph mCT or Biograph mCT Flow and should immediately contact their local Siemens Customer Service Engineer for correction of the problem.

Device

Biograph mCT and Biograph mCT Flow
  • Modèle / numéro de série
    Biograph mCT and Biograph mCT FlowCatalogue/Lot numbers: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10250743, 10250745, 10507786, 10528955, 10529159ARTG number: 144218
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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