Events

Retiro De Equipo (Recall) de GE MRI SystemsDiscovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR355, Twinspeed, Vectra, MR Max, Signa HDx/HDxt/HDi/ 1.5T HDe/Excite-HD 1.5T & 3T/ Excite 1.5T HD, Echospeed & Highspeed/ 1.5T Infinity TwinSpeed, EchoSpeed Plus & HiSpeed Plus/1.0T Infinity HiSpeed Plus & SmartSpeed/EXCITE 3.0T/ EXCITE 3.0T HD/ Excite 1.5T TwinSpeed & EchoSpeed, HiSpeed & SmartSpeed/ Excite 1.5T/ Excite 3.0T/ Contour/I / OpenSpeed/ Profile /Ovation / PET/MR

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-2015-RN-00265-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-25
  • 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-00265-1
  • 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
    It has come to the attention of ge healthcare systems that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. the most recently deployed on-site software version may include safety updates.
  • Acción
    It has come to the attention of GE Healthcare that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates that would be absent if a previous version was installed. This action has been closed-out on 05/08/2016.

Device

GE MRI SystemsDiscovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR...
  • Modelo / Serial
    GE MRI SystemsDiscovery MR450/MR750/ MR750W GEM, Optima MR360/ MR450w/MR450w GEM/ MR950, Brivo MR355, Twinspeed, Vectra, MR Max, Signa HDx/HDxt/HDi/ 1.5T HDe/Excite-HD 1.5T & 3T/ Excite 1.5T HD, Echospeed & Highspeed/ 1.5T Infinity TwinSpeed, EchoSpeed Plus & HiSpeed Plus/1.0T Infinity HiSpeed Plus & SmartSpeed/EXCITE 3.0T/ EXCITE 3.0T HD/ Excite 1.5T TwinSpeed & EchoSpeed, HiSpeed & SmartSpeed/ Excite 1.5T/ Excite 3.0T/ Contour/I / OpenSpeed/ Profile /Ovation / PET/MRARTG: 223115
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd