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-00005-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-03
  • 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-00005-1
  • 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 user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism., the swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. if the connection of the user interface module to the column on the ultrasound system is lose, the entire module may fall off the ultrasound system. there is a potential risk of striking and harming anyone in the environment of the ultrasound system.
  • Acción
    End users are advised to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. If looseness is observed, discontinue use immediately and contact a Siemens service representative. A service engineer will perform the necessary repairs.

Device

ACUSON SC2000 Ultrasound Systems
  • Modelo / Serial
    ACUSON SC2000 Ultrasound SystemsCatalogue Number: 10433816Serial Numbers lower than 401100ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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