Events

Retiro De Equipo (Recall) de Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products)

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-00927-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-01
  • 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-00927-1
  • 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 issue with the shortened battery life. shortened battery life can lead to a loss of power to devices plugged into the shuttle. power loss during transport most reasonably expected to occur from this battery issue may lead to a minor delay in the transport time.
  • Acción
    GE Healthcare is providing work around instructions for users to follow as an interim measure. GE Healthcare is providing a software update as a permanent fix. This action has been closed-out on 20/06/2016.

Device

Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products)
  • Modelo / Serial
    Giraffe Shuttle Products (uninterruptable power supply for Giraffe Products)Giraffe Shuttles with serial number MAAU61001 or higher are not affected by this issue.All shuttles shipped prior to 1 July 2015ARTG Number: 172411
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd