Events

Retiro De Equipo (Recall) de GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016

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-2016-RN-00502-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-27
  • 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-00502-1
  • 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
    Ge healthcare has become aware that an out of tolerance torque tool was used on three joints on your revolution ct system during the manufacturing process. if the x-ray tube becomes loose on the ct gantry during operation, this could result in beam tracking errors, potential scan aborts and/or a possible image artefact. there is a secondary safety mechanism to prevent components from being expelled from the gantry if the bolts fail. there have been no injuries reported as a result of this issue.
  • Acción
    GE Healthcare is advising users that the scanner can continue to be used. If the X-ray Tube joint loosens, the system would fail internal checks and cause the previous mentioned hazards of beam tracking errors, potential scan aborts and/or image artefacts, requiring immediate action by service to realign the system. Should this occur, stop using the system and call the service team to bring the system back into proper operational status. GE Healthcare will be correcting all affected products. This action has been closed-out on 27/01/2017.

Device

GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016
  • Modelo / Serial
    GE Revolution CT Computed Tomography X-ray systemsManufactured from July 2015 to March 2016ARTG Number: 156650
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd