Events

Retiro De Equipo (Recall) de Mammomat Inspiration System with software version VB30 and Biopsy functionality

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 Healthcare 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-2017-RN-00071-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-17
  • 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-2017-RN-00071-1
  • 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
    Siemens has become aware of potential errors that may occur while performing a biopsy. the system may freeze and biopsy functionality may become unavailable in the following situations:- drop of the compression force, e.G. this may occur due to a patient's sudden movement during the active targeting phase- use of the inversion tool while the scout image is active during the targeting phase.As a result of system freeze, the biopsy may have to be repeated.
  • Acción
    Siemens will release a software update to resolve the issue. Siemens service engineer will contact affected customers to schedule the software update. In the interim, Siemens is advising users to follow these instructions: 1) Do not close the error message window when it is displayed. Instead, cancel the active target before closing the window. Users can start all over after the completion of these steps. 2) Users are advised not to use the inversion tool while the scout image is active. In the event of a system freeze, the acquisition workplace must be rebooted.

Device

Mammomat Inspiration System with software version VB30 and Biopsy functionality
  • Modelo / Serial
    Mammomat Inspiration System with software version VB30 and Biopsy functionalityCatalogue Number: 10140000 (with software version VB30 and with a Biopsy option)ARTG Number: 274541
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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