Events

Retiro De Equipo (Recall) de ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02

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-2014-RN-00420-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-08
  • 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-00420-1
  • 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
    When foursight 4d ultrasound imaging, 3-scape real-time 3d imaging, or anatomical m-mode are used during an obstetric or gynecology studies, the following data from the previous patient could replace the current patient's data in the report:- clinical lmp (last menstrual period)- clinical edc (estimated date of confinement)- clinical ma (menstrual age)- indicationif the replaced data is not noticed, there is a potential risk of performing additional diagnostic or non-indicated therapeutic procedures.
  • Acción
    To avoid this scenario, the following steps are recommended by Siemens: - Always review the patient report at the end of each study and confirm the report contains only measurements and patient data relevant to the exam just performed. - Before exiting fourSight 4D ultrasound imaging or 3-Scape (3D) imaging access and review the patient report. This step refreshes the data in the report. A new version of software resolving the error will be implemented in the affected units.

Device

ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02
  • Modelo / Serial
    ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02Catalogue/Lot number – 1065844 ARTG number: 137563
  • Manufacturer
    Siemens Ltd

Manufacturer

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