Events

Retiro De Equipo (Recall) de Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty 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-01067-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-07
  • 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-01067-1
  • 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
    The epi2alt feature which is a type-in pulse sequence database (psd) recently introduced in the dv25 software release that was intended to help a different brand users transitioning to ge scanners, contains a software issue in which images may be flipped and annotated incorrectly. this image orientation error will affect all axial, sagittal, and coronal diffusion-weighted echo planar imaging (epi) scans using the ‘epi2alt’ type-in (psd) in conjunction with the ‘focus excitation’ option when the number of excitations (nex) is set to larger than 1. no other psds or imaging options are affected by this issue. no injuries have been reported due to this issue.
  • Acción
    GE Healthcare recommends that users discontinue use of the type-in ‘epi2alt’ PSD option. Users may continue to use all diffusion-weighted EPI scans available through the user interface.

Device

Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with t...
  • Modelo / Serial
    Discovery MR750, Optima MR450w equipped with the GEM option, and Discovery MR750w equipped with the GEM option products that are running DV 25 software release (MRI System)ARTG Number: 223115
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd