Events

Retiro De Equipo (Recall) de Centricity PACS RA1000 Workstation (Picture Archiving and Communication 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 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-00868-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-08-26
  • 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-00868-1
  • 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 of potential safety issues due to out of context and measurement issues associated with specific workflows of centricity pacs ra1000 workstations.
  • Acción
    GE Healthcare are providing a software update to correct the issue (version 4.0 SP3).The update can only be applied to versions 3.2.X and 4.01. Customers on previous versions must first upgrade to 3.2 before applying update 4.0 SP3. Once 4.0 SP3 (FMI 85285) is released, all media required to upgrade from 3.1.1.2 to 3.2 to 4.0 SP3 are included in the FMI 85285 media kit. Thia action has been closed on 28/01/2016

Device

Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)
  • Modelo / Serial
    Centricity PACS RA1000 Workstation (Picture Archiving and Communication System)All Versions below 4.0.3ARTG Number: 120196
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd