Events

Retiro De Equipo (Recall) de Revolution CT Scanners, software version 15MW03.12

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare 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-01058-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-28
  • 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-01058-1
  • 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
    A potential hazardous situation can occur during a routine head scan with possible artefacts that may emulate pathology between the brain tissue and bone in the head images. no injuries have been reported to date related to this issue.
  • Acción
    To minimise the effects of beam hardening artefacts during routine head scans, GE Healthcare recommends that in addition to the information in the existing CT User Manual, the site also follow the additional recommendations identified in the customer letter. GE Healthcare will be delivering an addendum to the User Manual that reiterates these mitigations. Additional improvements to image quality are currently in development. This software will be distributed and installed on affected systems. This action has been closed-out on 29/08/2016.

Device

Revolution CT Scanners, software version 15MW03.12

Manufacturer

GE Healthcare Australia Pty Ltd