Events

Retiro De Equipo (Recall) de Acuson SC200 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 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-00353-1
  • 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-00353-1
  • 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
    Due to an alignment issue with the bezel on the front panel, the plastic cover around the transducer ports prevents full contact of the connector on the transducer to the transducer port on the system. this issue causes the system to lock up.This may result in a delay in diagnosis while an alternative exam is performed.
  • Acción
    Siemens is advising users that in the event a transesophageal transducer is inserted in a patient, the user should first disconnect and reconnect the transducer. If the system still locks up, the user should then follow the instructions on the screen and disconnect the transducer, remove the transducer from the patient, and contact a Siemens service representative. Siemens will be replacing the front panel of the system as a permanent fix.

Device

Acuson SC200 ultrasound systems
  • Modelo / Serial
    Acuson SC200 ultrasound systemsAffected Serial Numbers: 400300 and belowCatalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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