Events

Retiro De Equipo (Recall) de Switch Point Infinity 3 (Operating Room 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 Stryker 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-01190-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-12-07
  • 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-01190-1
  • 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
    Stryker has become aware that for sources utilising s-video and composite inputs, phase alternating line (pal) signals appear with jagged edges on all diagonal lines resulting in poor video quality. the potential hazard associated with this failure is a pal signal used with s-video or composite input that produces an image that is not clear and free of artefacts.
  • Acción
    A Stryker Technical Service Representative will coordinate the update of affected devices. The update will correct the poor video quality as well as support for additional PAL resolution. This action has been closed-out on 29/08/2016.

Device

Switch Point Infinity 3 (Operating Room Management System)
  • Modelo / Serial
    Switch Point Infinity 3 (Operating Room Management System)Catalogue Number: 0678001000All serial numbers affectedARTG Number: 232446
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA