Events

Retiro De Equipo (Recall) de Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray 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 Hologic 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-2013-RN-00401-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-03
  • 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-00401-1
  • 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
    Hologic has identified the following compliance issues:1. the audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate. 2. the total cumulative irradiation time display is not accurate. both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions.
  • Acción
    Hologic is providing their customers with a revised version of the software. End users are requested to update their systems in accordance with the instructions provided with the update.

Device

Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)
  • Modelo / Serial
    Mini C-arm, models InSight and InSight 2 (Fluoroscopic x-ray system)ARTG 158774
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd