Events

Retiro De Equipo (Recall) de Invivo DynaCAD Breast and Prostate with software versions 3.4 and 3.5

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-2018-RN-00163-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-21
  • 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-2018-RN-00163-1
  • 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
    A problem was uncovered which causes images processed with pharmacokinetic (pk) results and/or dynacad calculated apparent diffusion coefficient (adc) maps have incorrect colour overlay results as well as in the case of the adc images, incorrect values reported. the defect exists on any dynacad client system running software versions 3.4 or 3.5.
  • Acción
    Philips is advising users to discontinue use of the Ktrans, Kep, and iAUGC colormaps when assessing studies from a remotely connected DynaCAD client computer. It is further advised that users refrain from using the colormaps and values derived from ADC maps calculated by DynaCAD. ADC maps originating natively from the MRI system should be used as an alternative as these values are unaffected. Philips will provide a v4.0 software update for the affected software versions as a permanent correction.

Device

Invivo DynaCAD Breast and Prostate with software versions 3.4 and 3.5
  • Modelo / Serial
    Invivo DynaCAD Breast and Prostate with software versions 3.4 and 3.5Multiple serial numbers affectedARTG Number: 230620
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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