Events

Retiro De Equipo (Recall) de Brainlab Offset Cup Impactor Universal

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-2015-RN-00066-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-23
  • 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-2015-RN-00066-1
  • 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
    It has been detected that, when the device is reprocessed according to the instructions in the current brainlab cleaning, disinfection and sterilization guide (revision 4.9 and previous), the device may not achieve sterility. the required sterility assurance level (sal) of 10-6 is not reliably achieved with the currently specified steam sterilization cycles and associated drying times.
  • Acción
    Brainlab is providing the updated instructions for use to end users. This action has been closed-out on 18/07/2016.

Device

Brainlab Offset Cup Impactor Universal
  • Modelo / Serial
    Brainlab Offset Cup Impactor Universal Model Number: 52856, 52856AARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd