Events

Retiro De Equipo (Recall) de Merge CADstream, All versions (used for breast cancer or general MRI studies)

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-2016-RN-00866-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-06
  • 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-2016-RN-00866-1
  • 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
    Within the sureloc application, under sureloc preferences, there are two grid options: a generic grid or the ge 8-channel curved grid. a generic grid is a flat grid of 2 centimeter holes. there is no limitation on the number of blocks. selecting the incorrect grid or using an unsupported grid could result in an incorrect biopsy or missed target. there is a chance that a repeat biopsy may be required.
  • Acción
    Emergo is advising users to ensure a verification scan is completed as per the User Guide to confirm correct placement prior to undertaking a biopsy. Users are also advised that if they are using a grid outside the two defined options, please contact Merge support. This action has been closed-out on 27/02/2017.

Device

Merge CADstream, All versions (used for breast cancer or general MRI studies)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia