Events

Retiro De Equipo (Recall) de Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray 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-2013-RN-00111-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-08
  • 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-2013-RN-00111-1
  • 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
    There is potential for malfunction in cases where the table vertical tilt movement is obstructed by a solid object resulting in a collision. this can result in damage to the system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. in this case, the table may drop resulting in potentially hazardous situations for patients and/or staff.
  • Acción
    Siemens is advising customers to avoid any collision of the table with objects in the table's operating area. Customers should contact their Siemens service representative for a precautionary inspection should such a collision occur or have occurred in the past.

Device

Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Lu...
  • Modelo / Serial
    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray systems)ARTG Numbers: 102181 & 144246
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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