Events

Rappel de Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01134-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-14
  • 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-01134-1
  • 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, fhc inc, has received two reports where the 5-hole metal insert of the frame adapter or positioner became loose. in both instances, the insert did not fall completely out of metal housing but loosened within the adapter. neither event resulted in patient injury. such looseness may result in a slight axial movement of the insert although fhc has not identified any significant patient risk as a result of this movement.
  • Action
    Users are advised to contact Emergo Australia to arrange for the return of affected devices to the manufacturer, FHC Inc, for repair. There are loan kits available for use until the devices are corrected.

Device

Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neur...
  • Modèle / numéro de série
    Star Drive Frame Adapters and Positioners (intended to be used with stereotactic systems for neurosurgical procedures for accurate positioning of mircoelectrodes, stimulating electrodes or other instruments in the brain or nervous system)Model Numbers: 70-LG-01, 70-FA-RD, 70-FA-LXSerial Numbers: 10205, 00001, 00002, 126279, 126314ARTG Number: 177545
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia