Events

Rappel de Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtel 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-2013-RN-01014-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-03
  • 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-01014-1
  • 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
    The manufacturer, magstim has identified a manufacturing non-conformity on a single 9784-00, magstim 90mm high power coil. the nature of the non-conformance is the omission of the insulating sleeving that is normally applied over the two solder joints between the coil winding and the red and black conductors in the coil cable. although the coil passed the safety tests and functional checks, the non-conformance resulted in an increase in the risks associated with the use of the coil and could have led to complete failure of the coil during usage. the failure mode would be such that a loud bang would be produced and the coil would cease to function. there could also be damage to the stimulator to which the coil was connected.
  • Action
    Medtel is requesting users to stop using the coils. Product can be returned to Medtel for replacement with unaffected stock.

Device

Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cor...
  • Modèle / numéro de série
    Magstim 90mm High Power Coil (used for diagnostic and therapeutic purposes by stimulating the cortical and peripheral nerves using the magnetic field)Part Number: 9784-00Serial Numbers: 2687, 2676ARTG Number: 136823
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA