Events

Retiro De Equipo (Recall) de Artis One in conjunction with table

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-2018-RN-00054-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-19
  • 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-2018-RN-00054-1
  • 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 has been made aware of an issue with the artis one systems in conjunction with artis tables. the artis table top carriage is mounted on top of the table base and fixed with a bolt. a fixation ring is used to secure the bolt. in the event of a missing or wrongly installed fixation ring, the bolt will remain in place and the patient table may appear to operate normally. in extreme cases after long periods of use, the bolt persistently bears the unexpected force from non-vertical direction and may slide out of its base and lead to the table top carriage slide to the floor. no complaints have been received for the artis one system to date.
  • Acción
    Siemens will be in contact with affected users to arrange for a service technician to examine potentially affected tables. The positioning of the bolt as well as the fixation rings will be verified and if necessary corrected or replaced.

Device

Artis One in conjunction with table
  • Modelo / Serial
    Artis One in conjunction with tableCatalogue number – 10848600ARTG number – 222194 (Siemens Healthcare Pty Ltd- Artis one - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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