Events

Retiro De Equipo (Recall) de GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T

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-00924-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-16
  • 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-00924-1
  • 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
    Ge has recently become aware of a potential safety issue with performing head or neck scans on the affected scanners. the currently displayed specific absorption rate (sar) values could be lower than the actual sar in the head and neck as predicted by sar modelling. the predicted head sar value from the modelling suggests the actual sar in the head could exceed iec60601-2-33 limit of 3.2 w/kg for some scans.When the system transmits rf power using the whole body rf transmit coil, the sar value displayed on the system user interface, will be shown as equal to the whole body sar; therefore the sar delivered to the head could be higher than the displayed sar value. if patients receive higher than expected radio-frequency (rf) energy absorbed during mr imaging procedures, specifically for patients with mr conditional implants, then localised deep-tissue heating or thermal injury in the vicinity of implants could occur. there have been no injuries identified as a result of this issue.
  • Acción
    GE Healthcare will correct all affected products. In the interim, for patients with MR conditional head and neck implants, customers are advised to use only the transmit/receive HEAD coil for conducting head and neck scans and to follow the implant’s labelling and instructions strictly. Also, do not scan patients with implants that have been labelled as MR Conditional with HEAD SAR requirements other than the IEC limit for 3.2 W/kg, as stated in the MR operator manual. For all patients, limit the length of scan protocols; specifically, do not scan any patient continuously without any break for longer than 100 minutes. As is the case for all MR imaging, follow Good Clinical Practices. This action has been closed-out on 07/09/2016.

Device

GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/...
  • Modelo / Serial
    GE 3.0T MR Systems (Full body MRI system):Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR 3.0T,SIGNA HDxt 3.0T, SIGNA HDx 3.0T, SIGNA HD 3.0T, SIGNA Excite 3.0T and SIGNA 3.0T ARTG Number: 223115
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd