Events

Retiro De Equipo (Recall) de ACUSON SC2000 ultrasound systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens 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-00035-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-19
  • 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-00035-1
  • 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
    An internal bolt intended to hold the control panel in a fixed position can fail. if this bolt fails, the operator cannot lock the control panel into position, and the steering and rotation of the console will also be affected. the up/down positioning is not affected. portable exams are not possible and bedside exams are more difficult without these positioning capabilities. there is potential risk for not controlling the system during transport or during a patient examination. potential harms include bruises, cuts, scrapes, or broken bones. to date no patient injury has been reported.
  • Acción
    Affected customers will be contacted by Siemens to schedule the necessary repairs on site. This action has been closed-out on 03/08/2016.

Device

ACUSON SC2000 ultrasound systems
  • Modelo / Serial
    ACUSON SC2000 ultrasound systemsSystem material number 10433816 (specific serial number range with component material number 10852376 installed)ARTG number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA