Events

Retiro De Equipo (Recall) de Acuson 2000 ultrasound system (with structural foam core).

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-2016-RN-00360-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-24
  • 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-2016-RN-00360-1
  • 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
    The metal component used to engage the lock on the wheels may disconnect, preventing the user from locking and unlocking or steering the wheels.In the event this issue occurs when the wheels are in the “unlocked” position and the user attempts to move the system, the user may lose balance. if the wheels are in the “locked” position and the user attempts to move the system, the user may sustain soft tissue damage or strain. to date, no patient injury has been reported.
  • Acción
    Siemens is advising that there are no known steps the user can take to prevent the issue from occurring. Siemens will be modifying the wheel assembly on affected systems as a permanent correction.

Device

Acuson 2000 ultrasound system (with structural foam core).
  • Modelo / Serial
    Acuson 2000 ultrasound system (with structural foam core).Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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