Events

Retiro De Equipo (Recall) de Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management 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 Device Technologies 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-2014-RN-00962-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-09-04
  • 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-2014-RN-00962-1
  • 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
    The manufacturer has identified two scenarios in which the mckesson cardiology hemo calculation section incorrectly converts the haemoglobin value before it is utilized in the applicable formula calculations. as a result, the formula output is incorrect. if the issue occurs, then for those procedures that use the specified formula calculations, the formula outputs will be incorrect. this may lead to delay in appropriate treatment or incorrecttreatment.
  • Acción
    McKesson will provide a resolution to this issue through a software update. A system check will also take place to identify any previous procedure calculations that may have been affected in your facility. Until the correction is completed additional procedures to ensure correct Hb values are requested to be carried out by end users. This action has been closed-out on 07/06/2016.

Device

Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)
  • Modelo / Serial
    Horizon Cardiology Hemo – versions 13.0 and 13.1 (cardiology/cath lab information management system)ARTG Number: 146573
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd