Events

Retiro De Equipo (Recall) de Standard Cranial Reference Array (used with Vector Vision Cranial Navigation 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 Brainlab Australia Pty Ltd.

¿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-2012-RN-00962-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-24
  • 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-2012-RN-00962-1
  • 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
    Manufacturing tolerance's of the standard cranial reference array influence the actual position of its marker spheres. the differences between the individual arrays are very small, not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery.This recall action was not notified to the tga before it was initiated by brainlab australia.
  • Acción
    The sponsor is advising users to follow work around instructions and will provide a hardware update to correct the issue.

Device

Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System)
  • Modelo / Serial
    Standard Cranial Reference Array (used with Vector Vision Cranial Navigation System)Product Codes: 41735 & 41730A
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd