Events

Retiro De Equipo (Recall) de Ultrasound Q-Station version 3.0 or higher

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2015-RN-00491-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-10
  • 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-2015-RN-00491-1
  • 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
    If a user opens a study for review on q-station before its transfer from the ultrasound system cart has completed, measurements from that study (structured report) may be appended to subsequent studies for other patients. as a result, measurements from one patient may be presented in another patient’s study, due to a failure to clear previous patient information when selecting the new study.This hazardous situation will exist only if all of the following events occur: a user performs and completes a study (study a) on the ultrasound system that includes sr (structured report) measurements and initiates the export of study a to q-station (‘manual’, ‘auto’ or ‘send as you scan’).The user opens study a for review on q-station using view/report/export before the transfer of the sr is complete. no reports of misdiagnosis or harm as a result of the data mixing have been received.
  • Acción
    Philips has corrected this issue via software version 3.3.2 and is sending a CD with this latest version of Q-Station to the affected customer, free of charge. This action has been closed-out on 17/08/2016.

Device

Ultrasound Q-Station version 3.0 or higher

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA