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-2014-RN-00076-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-23
  • 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-00076-1
  • 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 locking mechanism that is intended to hold the control panel in a fixed position can become loose and fail to lock the rotation of the control panel. if the locking mechanism fails, there is the potential risk the user will be unable to steer or control the ultrasound system during transport.
  • Acción
    Siemens is advising that if a user is unable to lock the rotation of the control panel or experiences rotation of the control panel or progressively greater left to right movement when the control panel lock is engaged, park the ultrasound system and contact Siemens. Siemens will be contacting all affected users to make the required repairs to the affected systems.

Device

ACUSON SC2000 Ultrasound Systems
  • Modelo / Serial
    ACUSON SC2000 Ultrasound SystemsSerial Numbers: 401100 to 401400ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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