Events

Retiro De Equipo (Recall) de Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)

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-2013-RN-01089-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-23
  • 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-2013-RN-01089-1
  • 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 recently become aware of a potential safety issue related to the manual film composer feature on some ct products. while following a specific workflow, there is potential to create a film image with one patient's images and another patient’s name in the footer. there is also another issue when within manual film composer, if a colour image is selected for printing, another patient’s black and white image appears in the preview screen and the colour image cannot be printed.
  • Acción
    As a temporary work around, GE is asking customers to always review the patient images and patient name on footer in the Manual Film Composer feature to ensure that they match . GE is providing temporary work around instructions on how to print the colour image from the Manual Film Composer. GE Healthcare will undertake a software update on each affected system as a permanent solution.

Device

Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)
  • Modelo / Serial
    Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)ARTG Number: 93337
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd