Events

Retiro De Equipo (Recall) de Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10C

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-00992-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-15
  • 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-00992-1
  • 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
    Loss of images - if an automatic ris worklist update is performed while a patient is already selected for examination, the subsequently acquired images of this patient might get lost under certain circumstances and cannot be recovered. this malfunction is not detectable to the user during the examination. only after the patient study is opened in the “examined patients” list, the user will be able to recognize that the acquired images are not available and irreversibly lost.Incorrect labels and annotations - under certain circumstances the image label (l, r) and annotations are displayed incorrectly after images have been sent to pacs or hardcopy/filming.
  • Acción
    Siemens are working on a software update to correct both malfunctions. In the interim Siemens is providing the following work around instructions: - To avoid the potential risk of lost images Siemens is advising their customers to disable the automatic RIS worklist update and perform this procedure manually. - To ensure the correct orientation of images Siemens recommends to always use lead letters to indicate patient orientation on the x-ray image. This action has been closed-out on 06/06/2016.

Device

Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10C
  • Modelo / Serial
    Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10CARTG numbers – 102184, 102182
  • Manufacturer
    Siemens Ltd

Manufacturer

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