Events

Retiro De Equipo (Recall) de SOMATOM go.Up and SOMATOM go. Now

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-01261-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-03
  • 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-2017-RN-01261-1
  • 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 healthcare have identified that the bolts on the patient table have been tightened with an inadequate torque, which may lead to a loose nut on the bolt. under unfavourable conditions several bolts may gradually loosen at the same time having an effect on the stability of the table.
  • Acción
    Siemens is advising users that if there is any unusual noise or vibration to cease use of the CT system and contact Siemens immediately. Siemens will be correcting all affected units.

Device

SOMATOM go.Up and SOMATOM go. Now
  • Modelo / Serial
    SOMATOM go.Up and SOMATOM go. Now Catalogue Numbers: 11061628 and 11061618ARTG Number: 142119
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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