Events

Rappel de MAGNUS Hybrid OR table column 1180.01B2

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Maquet Australia 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-00466-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-02
  • 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-00466-1
  • 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
    Maquet have been made aware of a complaint regarding a reported collision between the c-arm of the angiography-system and the magnus or table system. the root cause analysis has shown that the magnus column provided the wrong position data for the longitudinal movement. thus the collision calculation of the angiography-system led to an incorrect result. it was diagnosed that the magnus or table system may provide incorrect position data for particular movements in very rare cases after switching on the angiography-system. if this occurs, the system at the latest operates properly again after activating the corresponding movement.
  • Action
    A MAQUET service technician will be contacting users to arrange an appointment to update the software free of charge. Until that occurs users should activate all movements of the OR table system for a short time after switching on the angiography-system. The operator always has to observe the movement of the C-arm to have the possibility to react early enough if required.

Device

MAGNUS Hybrid OR table column 1180.01B2
  • Modèle / numéro de série
    MAGNUS Hybrid OR table column 1180.01B2Serial number 00001 to 00100
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    DHTGA