Events

Retiro De Equipo (Recall) de Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license)

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-2014-RN-01318-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-15
  • 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-2014-RN-01318-1
  • 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 a potential malfunction which can occur when composed images are flipped on the integrated imaging system flourospot compact. when composed images are flipped (vertically or horizontally) the image information might become corrupted as a result of a software malfunction. the affected images and associated annotations such as labels (e.G. r/l) may show incorrectly.The corrupt image information might lead to an incorrect diagnosis.
  • Acción
    Siemens is providing a new software version that will permanently resolve the described malfunction. In the interim end users are advised to follow work around instructions to ensure the safe use of the systems Ysio Max, Luminos dRF Max and Luminos Agile Max systems. This action has been closed-out on 08/08/2016.

Device

Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho...
  • Modelo / Serial
    Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license) ARTG Number: 102182, 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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