Events

Retiro De Equipo (Recall) de Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and reviewing haemodynamic parameters (vital signs) in cardiac catheterisation laboratories)

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-00735-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-04
  • 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-00735-1
  • 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
    Mckesson has identified that its communication to customers regarding the required maintenance tests was insufficient. while each unit has an attached sticker indicating the date of the next maintenance test the need for performing annual maintenance testing is not reiterated in 12.2 hf4 and earlier versions of the horizon cardiology hemo user guides. if the parameter boxes are not calibrated, the horizon cardiology hemo system may not function properly or potentially affect the accuracy of clinical parameters.
  • Acción
    Users are advised that the new version of the User Guide (12.2 version 5.0) is now available to address this issue and will be provided electronically upon request. The attachment provided with the customer letter identifies the updated sections of the new User Guide related to annual maintenance testing. This action has been closed-out on 02/02/2016.

Device

Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and revie...
  • Modelo / Serial
    Horizon Cardiology Hemo1 – versions 12.2 HF4 and earlier(used for acquiring, displaying and reviewing haemodynamic parameters (vital signs) in cardiac catheterisation laboratories)ARTG number: 146573
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd