Events

Retiro De Equipo (Recall) 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)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-01134-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01134-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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