Events

Retiro De Equipo (Recall) de Artis Systems in conjunction with Artis 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-2017-RN-00813-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-23
  • 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-2017-RN-00813-1
  • 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 identified an issue where large amounts of liquid can enter the artis table which may result in electric table movement failure. the patient table will not be able to be moved, or will only have limited movements. if function failure occurs, it could result in a situation where it may be necessary to cancel treatment or restart clinical treatment on a functioning system.
  • Acción
    Various gaps and openings on the top of the table will recieve additional sealing.

Device

Artis Systems in conjunction with Artis Table
  • Modelo / Serial
    Artis Systems in conjunction with Artis TableCatalogue Numbers: 5904441, 7728392, 7412807, 7413078, 7008605, 7555357, 7555373, 7727717, 10094141, 10094135, 10094137, 10280959, 10848281, 10848280, 10848283, 10848282 with Artis tableARTG Numbers: 273952, 222194 and 274081
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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