Events

Rappel de Aptio Automation Modules. 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-2016-RN-01310-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-10
  • 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-01310-1
  • 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 with the aptio automation modules. there is a possibility that the plug used to connect the automation system power source may overheat and fail. the plug used to connect to a standard power outlet is not affected.
  • Action
    Siemens is advising users to review customer letter with Medical Director, ensure all users are aware of the issue, return completed Response Form, retain letter with laboratory records and forward letter to those who may have received product. Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.

Device

Aptio Automation Modules. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Aptio Automation Modules. An in vitro diagnostic medical device (IVD).Module: Refrigerated Storage ModuleMaterial Number:10703049, 10715227, 10703036, 10713762 and 10713767Module: Centrifuge ModuleMaterial Number: 10703032, 10713761 and 10713764Module: i2000SR Interface ModuleMaterial Number: 10989303 and 10989304ARTG Number: 174699
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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